Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 7:11 AM
Study NCT ID:
NCT00856856
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABSORB Clinical Investigation, Cohort B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.veldhof@av.abbott.com', 'phone': '31653428610', 'title': 'Susan Veldhof', 'organization': 'Abbott Vascular International BVBA'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'The data for adverse event reporting \\& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \\& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \\& 5 years) and Group 2 (n = 56; followed for 1, 2 \\& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.', 'eventGroups': [{'id': 'EG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 58, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 84, 'numAffected': 44}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 30, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 40, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'In-stent coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac stress test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthritis reactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'PRIMARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'PRIMARY', 'title': 'In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS).\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm.\n\nCohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'PRIMARY', 'title': 'In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS).\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm.\n\nCohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Clinical Device Success (Per Lesion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On day 0 (the day of procedure)', 'description': 'Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Clinical Procedure Success (Per Patient)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On day 0 (the day of procedure)', 'description': 'Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Hierarchical Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABSORB Stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Scaffold Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS).\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm.\n\nCohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'ITT population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS).\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm.\n\nCohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. In Cohort B, Group 2. 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The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '19.21', 'spread': '7.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.', 'unitOfMeasure': 'percentage of diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '21.35', 'spread': '11.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.', 'unitOfMeasure': 'percentage of diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '20.94', 'spread': '7.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.', 'unitOfMeasure': 'percentage of diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '23.16', 'spread': '14.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.', 'unitOfMeasure': 'percentage of diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'In-scaffold Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '22.74', 'spread': '13.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.', 'unitOfMeasure': 'percentage of diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1 and Group2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population.Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Thrombus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Thrombus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Thrombus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population.Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Thrombus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Thrombus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Vasomotion Analysis: In-scaffold Mean Luminal Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'title': 'Pre-Nitro', 'categories': [{'measurements': [{'value': '2.49', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Post-Nitro', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Vasomotion function was assessed in reaction to nitrate administration.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Volume Obstruction (VO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '1.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.', 'unitOfMeasure': 'percent of scaffold volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B, Group 1. ITT population; Intravascular ultrasound (IVUS) analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Volume Obstruction (VO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '3.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.', 'unitOfMeasure': 'percent of scaffold volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Volume Obstruction (VO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'spread': '3.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.', 'unitOfMeasure': 'percent of scaffold volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B, Group 1. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Volume Obstruction (VO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'spread': '6.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.', 'unitOfMeasure': 'percent of scaffold volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Persisting Incomplete Apposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Persisting Incomplete Apposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort B, Group 2. Intent-to-treat (ITT) population. 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The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Luminal Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'spread': '0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. 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The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Luminal Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. 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Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Luminal Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. 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The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Stent Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Scaffold Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.19', 'spread': '0.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Scaffold Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Stent Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.74', 'spread': '0.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Scaffold Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.82', 'spread': '0.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Scaffold Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Strut Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '0.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Strut Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Strut Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts Per BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '162.1', 'spread': '31.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Number of Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts Per BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '160.9', 'spread': '27.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Number of Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts Per BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '145.2', 'spread': '32.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Number of Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts Per BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '29.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'unitOfMeasure': 'Number of Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Covered Struts (150 µm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.86', 'spread': '2.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Percent of Covered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Acutely Covered Struts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.07', 'spread': '3.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Percent of Covered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Acutely Covered Struts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.90', 'spread': '2.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Percent of Covered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Uncovered Struts (150 µm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '2.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Percent of Uncovered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Uncovered Struts (150 µm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.93', 'spread': '3.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Percent of Uncovered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '% of Uncovered Struts (150 µm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'spread': '2.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Percent of Uncovered Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts in Side Branch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Number of struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts in Side Branch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Number of struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts in Side Branch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Number of struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Struts in Side Branch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'unitOfMeasure': 'Number of struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area BVS (Neointimal Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.27', 'spread': '13.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.40', 'spread': '12.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.61', 'spread': '11.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.40', 'spread': '11.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'spread': '0.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area BVS (Neointimal Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '0.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.12', 'spread': '10.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.51', 'spread': '10.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.10', 'spread': '8.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.22', 'spread': '7.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.44', 'spread': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Area BVS (Neointimal Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.76', 'spread': '11.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.47', 'spread': '11.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume Classical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.36', 'spread': '7.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tissue Coverage Obstruction Volume BVS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.01', 'spread': '7.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Percent of Tissue Coverage Obstruction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.90', 'spread': '1.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.28', 'spread': '1.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Strut Core Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent (%) Lumen Area Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.70', 'spread': '12.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'Percentage of Lumen Area Stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'spread': '1.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'spread': '1.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Strut Core Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent (%) Lumen Area Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.75', 'spread': '10.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'Percentage of Lumen Area Stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.06', 'spread': '1.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.45', 'spread': '1.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Strut Core Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '0.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent (%) Lumen Area Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.01', 'spread': '13.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'unitOfMeasure': 'Percentage of Lumen Area Stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'spread': '1.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'spread': '1.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent (%) Lumen Area Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Target lesions', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.32', 'spread': '16.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'unitOfMeasure': 'Percentage of Lumen Area Stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Target lesions', 'denomUnitsSelected': 'Target lesions', 'populationDescription': 'Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '30-day Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '180-day Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '270-day Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '1-year Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '2-year Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': '3-year Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '4-year Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Missed visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': '5-year Clinical Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient missed the 4-year clinical follow-up but returned at 5 year.', 'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total of 101 patients (intent to treat patient population \\[ITT\\]) were enrolled in the ABSORB Cohort B study at 12 clinical sites in Europe/Australia/New Zealand between March 19, 2009 and November 6, 2009. Only for assessing imaging outcomes at different follow-up periods, subjects were divided into Group 1 (n = 45) \\& Group 2 (n = 56).', 'preAssignmentDetails': 'ITT population were assessed for all clinical endpoints. For imaging outcomes,Group 1 (n=45) patients were followed up at 180 days, 2 \\& 5 years; while Group 2 (n=56) patients at 1, 3 \\& 5 years. Therefore, data related to imaging outcomes are available only for Group 1 at 180 days, 2 \\& 5 years timeframe \\& only for Group 2 at 1, 3 \\& 5 years timeframe'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Absorb BVS', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)\n\nBioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease.\n\nInvestigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'groupId': 'BG000', 'lowerLimit': '60.4', 'upperLimit': '64.6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The patient demographics for the full Cohort B 101 patients (Group 1, 45 patients and Group 2, 56 patients) are described.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2009-02-27', 'resultsFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-04', 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Reference Area', 'timeFrame': '1 year'}, {'measure': 'Mean Reference Area', 'timeFrame': '2 years'}, {'measure': 'Mean Reference Area', 'timeFrame': '3 years'}, {'measure': 'Mean Reference Area', 'timeFrame': '5 years'}, {'measure': 'Mean Luminal Area', 'timeFrame': '1 year'}, {'measure': 'Mean Luminal Area', 'timeFrame': '2 years'}, {'measure': 'Mean Luminal Area', 'timeFrame': '3 years'}, {'measure': 'Mean Luminal Area', 'timeFrame': '5 years'}, {'measure': 'Minimum Luminal Area', 'timeFrame': '1 year'}, {'measure': 'Minimum Luminal Area', 'timeFrame': '2 years'}, {'measure': 'Minimum Luminal Area', 'timeFrame': '3 years'}, {'measure': 'Minimum Luminal Area', 'timeFrame': '5 years'}, {'measure': 'Mean Stent Area', 'timeFrame': '1 year'}, {'measure': 'Mean Scaffold Area', 'timeFrame': '2 years'}, {'measure': 'Mean Scaffold Area', 'timeFrame': '3 years'}, {'measure': 'Minimum Stent Area', 'timeFrame': '1 year'}, {'measure': 'Minimum Scaffold Area', 'timeFrame': '2 year'}, {'measure': 'Minimum Scaffold Area', 'timeFrame': '3 years'}, {'measure': 'Luminal Volume', 'timeFrame': '1 year'}, {'measure': 'Luminal Volume', 'timeFrame': '2 years'}, {'measure': 'Luminal Volume', 'timeFrame': '3 years'}, {'measure': 'Luminal Volume', 'timeFrame': '5 years'}, {'measure': 'Stent Volume', 'timeFrame': '1 year'}, {'measure': 'Scaffold Volume', 'timeFrame': '2 years'}, {'measure': 'Scaffold Volume', 'timeFrame': '3 years'}, {'measure': 'Mean Luminal Diameter', 'timeFrame': '1 year'}, {'measure': 'Mean Luminal Diameter', 'timeFrame': '2 years'}, {'measure': 'Mean Luminal Diameter', 'timeFrame': '3 years'}, {'measure': 'Mean Luminal Diameter', 'timeFrame': '5 years', 'description': 'It is measured during QCA by the Angiographic Core Lab.'}, {'measure': 'Minimum Luminal Diameter (MLD)', 'timeFrame': '1 year', 'description': 'The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.'}, {'measure': 'Minimum Luminal Diameter', 'timeFrame': '2 years', 'description': 'The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.'}, {'measure': 'Minimum Luminal Diameter', 'timeFrame': '3 years', 'description': 'The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.'}, {'measure': 'Minimum Luminal Diameter', 'timeFrame': '5 years', 'description': 'The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.'}, {'measure': 'Mean Stent Diameter', 'timeFrame': '1 year'}, {'measure': 'Mean Scaffold Diameter', 'timeFrame': '2 years'}, {'measure': 'Mean Scaffold Diameter', 'timeFrame': '3 years'}, {'measure': 'Minimum Stent Diameter', 'timeFrame': '1 year'}, {'measure': 'Minimum Scaffold Diameter', 'timeFrame': '2 years'}, {'measure': 'Minimum Scaffold Diameter', 'timeFrame': '3 years'}, {'measure': 'Strut Volume', 'timeFrame': '1 year'}, {'measure': 'Strut Volume', 'timeFrame': '2 years'}, {'measure': 'Strut Volume', 'timeFrame': '3 years'}, {'measure': 'Number of Struts Per BVS', 'timeFrame': '1 year'}, {'measure': 'Number of Struts Per BVS', 'timeFrame': '2 years'}, {'measure': 'Number of Struts Per BVS', 'timeFrame': '3 years'}, {'measure': 'Number of Struts Per BVS', 'timeFrame': '5 years'}, {'measure': '% of Covered Struts (150 µm)', 'timeFrame': '1 year'}, {'measure': '% of Acutely Covered Struts', 'timeFrame': '2 years'}, {'measure': '% of Acutely Covered Struts', 'timeFrame': '3 years'}, {'measure': '% of Uncovered Struts (150 µm)', 'timeFrame': '1 year'}, {'measure': '% of Uncovered Struts (150 µm)', 'timeFrame': '2 years'}, {'measure': '% of Uncovered Struts (150 µm)', 'timeFrame': '3 years'}, {'measure': 'Number of Struts in Side Branch', 'timeFrame': '1 year'}, {'measure': 'Number of Struts in Side Branch', 'timeFrame': '2 years'}, {'measure': 'Number of Struts in Side Branch', 'timeFrame': '3 years'}, {'measure': 'Number of Struts in Side Branch', 'timeFrame': '5 years'}, {'measure': 'Tissue Coverage Area Classical', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Area BVS (Neointimal Area)', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Volume Classical', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Volume BVS', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Obstruction Volume Classical', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Obstruction Volume BVS', 'timeFrame': '1 year'}, {'measure': 'Tissue Coverage Area Classical', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Area BVS (Neointimal Area)', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Volume Classical', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Volume BVS', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Obstruction Volume Classical', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Obstruction Volume BVS', 'timeFrame': '2 years'}, {'measure': 'Tissue Coverage Area Classical', 'timeFrame': '3 years'}, {'measure': 'Tissue Coverage Area BVS (Neointimal Area)', 'timeFrame': '3 years'}, {'measure': 'Tissue Coverage Volume Classical', 'timeFrame': '3 years'}, {'measure': 'Tissue Coverage Volume BVS', 'timeFrame': '3 years'}, {'measure': 'Tissue Coverage Obstruction Volume Classical', 'timeFrame': '3 years'}, {'measure': 'Tissue Coverage Obstruction Volume BVS', 'timeFrame': '3 years'}, {'measure': 'Mean Flow Area', 'timeFrame': '1 year'}, {'measure': 'Minimum Flow Area', 'timeFrame': '1 year'}, {'measure': 'Mean Strut Core Area', 'timeFrame': '1 year'}, {'measure': 'Percent (%) Lumen Area Stenosis', 'timeFrame': '1 year'}, {'measure': 'Mean Flow Area', 'timeFrame': '2 years'}, {'measure': 'Minimum Flow Area', 'timeFrame': '2 years'}, {'measure': 'Mean Strut Core Area', 'timeFrame': '2 years'}, {'measure': 'Percent (%) Lumen Area Stenosis', 'timeFrame': '2 years'}, {'measure': 'Mean Flow Area', 'timeFrame': '3 years'}, {'measure': 'Minimum Flow Area', 'timeFrame': '3 years'}, {'measure': 'Mean Strut Core Area', 'timeFrame': '3 years'}, {'measure': 'Percent (%) Lumen Area Stenosis', 'timeFrame': '3 years'}, {'measure': 'Mean Flow Area', 'timeFrame': '5 years'}, {'measure': 'Minimum Flow Area', 'timeFrame': '5 years'}, {'measure': 'Percent (%) Lumen Area Stenosis', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '30 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '1 year', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days', 'timeFrame': '180 days', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.'}, {'measure': 'In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year', 'timeFrame': '1 year', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up'}], 'secondaryOutcomes': [{'measure': 'Clinical Device Success (Per Lesion)', 'timeFrame': 'On day 0 (the day of procedure)', 'description': 'Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.'}, {'measure': 'Clinical Procedure Success (Per Patient)', 'timeFrame': 'On day 0 (the day of procedure)', 'description': 'Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '180 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '270 days', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '2 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '3 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '4 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Major Adverse Cardiac Event (MACE)', 'timeFrame': '5 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '30 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '180 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '270 days', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '1 year', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '2 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '3 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '4 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Hierarchical Target Vessel Failure (TVF)', 'timeFrame': '5 years', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '30 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '180 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '270 days', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '1 year', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '2 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '3 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '4 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Lesion Revascularization (ID-TLR)', 'timeFrame': '5 years', 'description': 'ID-TLR is defined as the revascularization at the target lesion associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '30 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '180 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '270 days', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '1 year', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '2 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '3 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '4 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Ischemia Driven Target Vessel Revascularization (ID-TVR)', 'timeFrame': '5 years', 'description': 'ID-TVR is the revascularization in the target vessel associated with any of the following:\n\n* Positive functional ischemia study\n* Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)\n* Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.'}, {'measure': 'Cardiac Death', 'timeFrame': '30 days', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Cardiac Death', 'timeFrame': '1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Cardiac Death', 'timeFrame': '2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Cardiac Death', 'timeFrame': '3 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Cardiac Death', 'timeFrame': '4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Cardiac Death', 'timeFrame': '5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded.\n\n(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)'}, {'measure': 'Myocardial Infarction', 'timeFrame': '30 days', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Myocardial Infarction', 'timeFrame': '1 year', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Myocardial Infarction', 'timeFrame': '2 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Myocardial Infarction', 'timeFrame': '3 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Myocardial Infarction', 'timeFrame': '4 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Myocardial Infarction', 'timeFrame': '5 years', 'description': 'Myocardial Infarction (MI):\n\n* Q wave MI: Development of new, pathological Q wave on the ECG.\n* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '30 days', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '1 year', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '2 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '3 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '4 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'Scaffold Thrombosis', 'timeFrame': '5 years', 'description': 'Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\\>1day ≤ 30 days) and late (\\>30 days) and will be defined as any of the following:\n\n* Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)\n* In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\\* in the distribution of the target lesion within 30 days \\*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)\n\nAny thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.'}, {'measure': 'In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years', 'timeFrame': '2 years', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.'}, {'measure': 'In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years', 'timeFrame': '3 years', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.'}, {'measure': 'In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years', 'timeFrame': '5 years', 'description': 'In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.'}, {'measure': 'Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days', 'timeFrame': '180 days', 'description': 'Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).'}, {'measure': 'Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year', 'timeFrame': '1 year', 'description': 'Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).'}, {'measure': 'Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years', 'timeFrame': '2 years', 'description': 'Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).'}, {'measure': 'Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years', 'timeFrame': '3 years', 'description': 'Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).'}, {'measure': 'Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years', 'timeFrame': '5 years', 'description': 'Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).'}, {'measure': 'Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days', 'timeFrame': '180 days', 'description': 'Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).'}, {'measure': 'Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year', 'timeFrame': '1 year', 'description': 'Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).'}, {'measure': 'Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years', 'timeFrame': '2 years', 'description': 'Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).'}, {'measure': 'Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years', 'timeFrame': '3 years', 'description': 'Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).'}, {'measure': 'Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years', 'timeFrame': '5 years', 'description': 'Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).'}, {'measure': 'In-scaffold Angiographic Binary Restenosis (ABR)', 'timeFrame': '180 days', 'description': 'Percent of patients with a followup percent diameter stenosis of \\>=50% per QCA.'}, {'measure': 'In-scaffold Angiographic Binary Restenosis (ABR)', 'timeFrame': '1 year', 'description': 'Percent of patients with a followup percent diameter stenosis of \\>=50% per QCA.'}, {'measure': 'In-scaffold Angiographic Binary Restenosis (ABR)', 'timeFrame': '2 years', 'description': 'Percent of patients with a followup percent diameter stenosis of \\>=50% per QCA.'}, {'measure': 'In-scaffold Angiographic Binary Restenosis (ABR)', 'timeFrame': '3 years', 'description': 'Percent of patients with a followup percent diameter stenosis of \\>=50% per QCA.'}, {'measure': 'In-scaffold Angiographic Binary Restenosis (ABR)', 'timeFrame': '5 years', 'description': 'Percent of patients with a followup percent diameter stenosis of \\>=50% per QCA.'}, {'measure': 'Persisting Dissection', 'timeFrame': '180 days', 'description': 'Dissection at follow-up that was present post-procedure.'}, {'measure': 'Persisting Dissection', 'timeFrame': '1 year', 'description': 'Dissection at follow-up that was present post-procedure.'}, {'measure': 'Persisting Dissection', 'timeFrame': '2 years', 'description': 'Dissection at follow-up that was present post-procedure.'}, {'measure': 'Persisting Dissection', 'timeFrame': '3 years', 'description': 'Dissection at follow-up that was present post-procedure.'}, {'measure': 'Persisting Dissection', 'timeFrame': '5 years', 'description': 'Dissection at follow-up that was present post-procedure.'}, {'measure': 'In-scaffold Percent Diameter Stenosis (%DS)', 'timeFrame': '180 days', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.'}, {'measure': 'In-scaffold Percent Diameter Stenosis (%DS)', 'timeFrame': '1 year', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.'}, {'measure': 'In-scaffold Percent Diameter Stenosis (%DS)', 'timeFrame': '2 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.'}, {'measure': 'In-scaffold Percent Diameter Stenosis (%DS)', 'timeFrame': '3 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.'}, {'measure': 'In-scaffold Percent Diameter Stenosis (%DS)', 'timeFrame': '5 years', 'description': 'Percent Diameter Stenosis is defined as the value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.'}, {'measure': 'Aneurysm', 'timeFrame': '180 days', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times."}, {'measure': 'Aneurysm', 'timeFrame': '1 year', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times."}, {'measure': 'Aneurysm', 'timeFrame': '2 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times."}, {'measure': 'Aneurysm', 'timeFrame': '3 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times."}, {'measure': 'Aneurysm', 'timeFrame': '5 years', 'description': "An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times."}, {'measure': 'Thrombus', 'timeFrame': '180 days'}, {'measure': 'Thrombus', 'timeFrame': '1 year'}, {'measure': 'Thrombus', 'timeFrame': '2 years'}, {'measure': 'Thrombus', 'timeFrame': '3 years'}, {'measure': 'Thrombus', 'timeFrame': '5 years'}, {'measure': 'Vasomotion Analysis: In-scaffold Mean Luminal Diameter', 'timeFrame': '5 years', 'description': 'Vasomotion function was assessed in reaction to nitrate administration.'}, {'measure': 'Volume Obstruction (VO)', 'timeFrame': '180 days', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.'}, {'measure': 'Volume Obstruction (VO)', 'timeFrame': '1 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.'}, {'measure': 'Volume Obstruction (VO)', 'timeFrame': '2 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.'}, {'measure': 'Volume Obstruction (VO)', 'timeFrame': '3 year', 'description': 'Defined as scaffold intimal hyperplasia and calculated as 100\\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.'}, {'measure': 'Persisting Incomplete Apposition', 'timeFrame': '180 days', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Persisting Incomplete Apposition', 'timeFrame': '1 year', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Persisting Incomplete Apposition', 'timeFrame': '2 year', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Persisting Incomplete Apposition', 'timeFrame': '3 year', 'description': 'Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Late Incomplete Apposition', 'timeFrame': '180 days', 'description': 'Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Late Incomplete Apposition', 'timeFrame': '1 year', 'description': 'Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Late Incomplete Apposition', 'timeFrame': '2 year', 'description': 'Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}, {'measure': 'Late Incomplete Apposition', 'timeFrame': '3 year', 'description': 'Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.\n\nIncomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioabsorbable', 'Coronary Stent', 'Everolimus', 'Drug eluting stents', 'Stents', 'Angioplasty', 'Coronary artery disease (CAD)', 'Total coronary occlusion', 'Coronary artery restenosis', 'Stent thrombosis', 'Vascular disease', 'Myocardial ischemia', 'Coronary artery stenosis'], 'conditions': ['Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']}, 'referencesModule': {'references': [{'pmid': '29247976', 'type': 'DERIVED', 'citation': 'Zeng Y, Cavalcante R, Collet C, Tenekecioglu E, Sotomi Y, Miyazaki Y, Katagiri Y, Asano T, Abdelghani M, Nie S, Bourantas CV, Bruining N, Onuma Y, Serruys PW. Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study. Atherosclerosis. 2018 Feb;269:6-13. doi: 10.1016/j.atherosclerosis.2017.11.002. Epub 2017 Dec 2.'}, {'pmid': '28893770', 'type': 'DERIVED', 'citation': 'Onuma Y, Grundeken MJ, Nakatani S, Asano T, Sotomi Y, Foin N, Ng J, Okamura T, Wykrzykowska JJ, de Winter RJ, van Geuns RJ, Koolen J, Christiansen EH, Whitbourn R, McClean D, Smits P, Windecker S, Ormiston JA, Serruys PW. Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). 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Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014 Dec;7(12):1400-11. doi: 10.1016/j.jcin.2014.06.016.'}, {'pmid': '25457053', 'type': 'DERIVED', 'citation': 'Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW; ABSORB Cohort B Study Investigators. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv. 2014 Dec;7(12):1361-9. doi: 10.1016/j.jcin.2014.06.025. Epub 2014 Nov 12.'}, {'pmid': '24746650', 'type': 'DERIVED', 'citation': 'Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.'}, {'pmid': '24291783', 'type': 'DERIVED', 'citation': 'Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.'}, {'pmid': '23048057', 'type': 'DERIVED', 'citation': 'Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.'}, {'pmid': '22516401', 'type': 'DERIVED', 'citation': 'Gutierrez-Chico JL, Gijsen F, Regar E, Wentzel J, de Bruyne B, Thuesen L, Ormiston J, McClean DR, Windecker S, Chevalier B, Dudek D, Whitbourn R, Brugaletta S, Onuma Y, Serruys PW. Differences in neointimal thickness between the adluminal and the abluminal sides of malapposed and side-branch struts in a polylactide bioresorbable scaffold: evidence in vivo about the abluminal healing process. JACC Cardiovasc Interv. 2012 Apr;5(4):428-35. doi: 10.1016/j.jcin.2011.12.015.'}, {'pmid': '22209268', 'type': 'DERIVED', 'citation': 'Brugaletta S, Radu MD, Garcia-Garcia HM, Heo JH, Farooq V, Girasis C, van Geuns RJ, Thuesen L, McClean D, Chevalier B, Windecker S, Koolen J, Rapoza R, Miquel-Hebert K, Ormiston J, Serruys PW. Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: can the scaffold cap the plaque? Atherosclerosis. 2012 Mar;221(1):106-12. doi: 10.1016/j.atherosclerosis.2011.12.008. Epub 2011 Dec 13.'}, {'pmid': '22104034', 'type': 'DERIVED', 'citation': 'Gutierrez-Chico JL, Radu MD, Diletti R, Sheehy A, Kossuth MB, Oberhauser JP, Glauser T, Harrington J, Rapoza RJ, Onuma Y, Serruys PW. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold. Circ J. 2012;76(2):342-50. doi: 10.1253/circj.cj-11-0726. Epub 2011 Nov 19.'}, {'pmid': '21958884', 'type': 'DERIVED', 'citation': 'Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.'}, {'pmid': '21939939', 'type': 'DERIVED', 'citation': 'Gomez-Lara J, Radu M, Brugaletta S, Farooq V, Diletti R, Onuma Y, Windecker S, Thuesen L, McClean D, Koolen J, Whitbourn R, Dudek D, Smits PC, Regar E, Veldhof S, Rapoza R, Ormiston JA, Garcia-Garcia HM, Serruys PW. Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. 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Epub 2011 Feb 26.'}, {'pmid': '21098436', 'type': 'DERIVED', 'citation': 'Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.'}, {'pmid': '21087756', 'type': 'DERIVED', 'citation': 'Gomez-Lara J, Garcia-Garcia HM, Onuma Y, Garg S, Regar E, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Dorange C, Veldhof S, Morel MA, de Vries T, Ormiston JA, Serruys PW. A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC Cardiovasc Interv. 2010 Nov;3(11):1190-8. doi: 10.1016/j.jcin.2010.07.016.'}, {'pmid': '20723856', 'type': 'DERIVED', 'citation': 'Okamura T, Onuma Y, Garcia-Garcia HM, Regar E, Wykrzykowska JJ, Koolen J, Thuesen L, Windecker S, Whitbourn R, McClean DR, Ormiston JA, Serruys PW; ABSORB Cohort B Investigators. 3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification. JACC Cardiovasc Interv. 2010 Aug;3(8):836-44. doi: 10.1016/j.jcin.2010.05.011.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov/ct2/show/NCT00300131?term=absorb&rank=1', 'label': 'Absorb, cohort A'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.\n\nCurrently in development at Abbott Vascular. Not available for sale in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'General inclusion criteria\n\n1. Patient must be at least 18 years of age.\n2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.\n3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)\n4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery\n5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)\n6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure\n\nAngiographic Inclusion Criteria\n\n1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm\n2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation\n3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \\< 100% with a TIMI flow of ≥ 1\n4. If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches\n5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria\n6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure\n7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \\> 6 months prior to or if planned to be done 6 months after the index procedure\n\nGeneral Exclusion Criteria\n\n1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure\n2. The patient is currently experiencing clinical symptoms consistent with AMI\n3. Patient has current unstable arrhythmias\n4. Patient has a known left ventricular ejection fraction (LVEF) \\< 30%\n5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant\n6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure\n7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)\n8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)\n9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated\n10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel\n11. Patient has a platelet count \\< 100,000 cells/mm3 or \\> 700,000 cells/mm3, a white blood cell count of \\< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)\n12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)\n13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions\n14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months\n15. Patient has had a significant GI or urinary bleed within the past six months\n16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion\n17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)\n18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint\n19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)\n20. Patient has received brachytherapy in any epicardial vessel (including side branches)\n\nAngiographic Exclusion Criteria\n\n1. Target lesion(s) meets any of the following criteria:\n\n 1. Aorto-ostial location (within 3 mm)\n 2. Left main location\n 3. Located within 2 mm of the origin of the LAD or LCX\n 4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \\> 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft\n 5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion \\> 40% stenosed by visual estimation or side branch requiring predilatation\n 6. Total occlusion (TIMI flow 0), prior to wire crossing\n 7. Excessive tortuosity proximal to or within the lesion\n 8. Extreme angulation (≥ 90%) proximal to or within the lesion\n 9. Heavy calcification\n 10. Restenotic from previous intervention\n2. The target vessel contains visible thrombus\n3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)\n4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)'}, 'identificationModule': {'nctId': 'NCT00856856', 'acronym': 'ABSORB B', 'briefTitle': 'ABSORB Clinical Investigation, Cohort B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.', 'orgStudyIdInfo': {'id': '05-370 Cohort B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Absorb stent', 'description': 'Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)', 'interventionNames': ['Device: Bioabsorbable Everolimus Eluting Coronary Stent']}], 'interventions': [{'name': 'Bioabsorbable Everolimus Eluting Coronary Stent', 'type': 'DEVICE', 'description': 'Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease', 'armGroupLabels': ['Absorb stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3065', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Monash Heart', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze-Lieve VrouweZiekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Skejby Sygehus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Massy', 'country': 'France', 'facility': 'Institut Hospitalier Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina ZH Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern, Kardiologie', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Patrick Serruys, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Heart Center, Thorax Centrum'}, {'name': 'John Ormiston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auckland City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}