Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 7:42 PM
Study NCT ID:
NCT02513732
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hajime.kusano@abbott.com', 'phone': '+1 4088451626', 'title': 'Hajime Kusano, Senior Adviser Clinical', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 Years', 'description': 'In this surveillance, Investigators report Serious Adverse event, Cardiac Adverse Event, DAPT related AE and Device Deficiency as per local regulation and protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 67, 'seriousNumAtRisk': 100, 'deathsNumAffected': 9, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastric ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bladder tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Device-related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery no-reflow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastric ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bladder tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Device-related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Stent Thrombosis: Late', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days to 1 year post stent implantation-Day 212', 'description': 'Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.\n\nTimings:\n\nAcute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \\>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \\>1 year post stent implantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intend To Treat population(ITT population)'}, {'type': 'SECONDARY', 'title': 'Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '72.02', 'spread': '16.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).', 'unitOfMeasure': 'Percent Diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions', 'denomUnitsSelected': 'Number of lesions', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '23.15', 'spread': '12.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).', 'unitOfMeasure': 'Percent Diameter stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions', 'denomUnitsSelected': 'Number of lesions', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percent Diameter Stenosis (%DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}, {'units': 'Number of lesions', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '32.14', 'spread': '20.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).', 'unitOfMeasure': 'Percent Diameter Stenosis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions', 'denomUnitsSelected': 'Number of lesions', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline before procedure', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Date of discharge from procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 months observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antiplatelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Aspirin + clopidogrel', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin + ticlopidine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspirin', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Clopidogrel', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Prasugrel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Ticlodipine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cilostazol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Compounding agent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 Years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MI Related to Target Vessel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven 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'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 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non-ischemia driven TVR (TLR or TVR, nonTLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 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'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), 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other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death/All MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 8 months', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 1 year', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 2 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 3 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 4 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Target Lesion Failure (TLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 5 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Acute Gain: In-stent, In-segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Stent', 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Segment', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8 months, post index procedure', 'description': 'The difference between post- and pre-procedural MLD.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Stent', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Proximal', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Distal', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Segment', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8 months, post index procedure', 'description': 'Late loss is calculated as MLD post procedure - MLD at follow-up.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Net Gain: In-stent, In-segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'title': 'Stent', 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Segment', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8 months, post index procedure', 'description': 'Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Lesion Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '17.38', 'spread': '10.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'The lesion length will be measured by QCA.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Minimum Blood Vessel Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'Minimum blood vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Minimum Blood Vessel Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure', 'description': 'Minimum blood vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Minimum Blood Vessel Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'Minimum blood vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}, {'type': 'SECONDARY', 'title': 'Mean Reference Vessel Diameter (RVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'Reference vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions', 'denomUnitsSelected': 'Number of lesions', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Mean Reference Vessel Diameter (RVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure', 'description': 'Reference vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Mean Reference Vessel Diameter (RVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}, {'units': 'Number of lesions QCA', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'spread': '0.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'Reference vessel diameter measured by QCA', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of lesions QCA', 'denomUnitsSelected': 'Number of lesions QCA', 'populationDescription': 'The number of participants analyzed includes subjects who had available follow up data at that time frame.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Changing hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 100 subjects were enrolled from multiple sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'XIENCE Xpedition 2.25 mm Stent Arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.58', 'spread': '8.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '64.22', 'spread': '10.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.23', 'spread': '2.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 100 patients were treated with Xience Xpedition 2.25 mm stent'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-20', 'size': 217837, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-25T09:21', 'hasProtocol': True}, {'date': '2015-06-23', 'size': 557592, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-25T09:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2015-07-17', 'resultsFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-27', 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Stent Thrombosis: Late', 'timeFrame': '30 days to 1 year post stent implantation-Day 212', 'description': 'Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.\n\nTimings:\n\nAcute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \\>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \\>1 year post stent implantation'}], 'secondaryOutcomes': [{'measure': 'Percent Diameter Stenosis (%DS)', 'timeFrame': 'Pre-procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).'}, {'measure': 'Percent Diameter Stenosis (%DS)', 'timeFrame': 'Immediately after the procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).'}, {'measure': 'Percent Diameter Stenosis (%DS)', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'In-segment, In-stent, Proximal and Distal. The value calculated as 100 \\* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': 'At baseline before procedure', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': 'Date of discharge from procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '8 months observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '1 year observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '2 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '3 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '4 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants Using Antiplatelet Therapy', 'timeFrame': '5 years observation day from the procedure day', 'description': 'Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.'}, {'measure': 'Number of Participants With Death', 'timeFrame': 'During hospitalization', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 8 months', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 1 year', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 2 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 3 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 4 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Death', 'timeFrame': '0 to 5 years', 'description': 'All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.\n\n* Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n* Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n* Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': 'During hospitalization', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 8 months', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 1 year', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 2 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 3 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 4 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Target Lesion Revascularization Based on Ischemia Findings', 'timeFrame': '0 to 5 years', 'description': 'Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.'}, {'measure': 'Number of Participants With Myocardial Infarction', 'timeFrame': 'During hospitalization', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 8 months', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 1 year', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 2 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 3 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 4 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Myocardial Infarction', 'timeFrame': '0 to 5 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Cardiac Death', 'timeFrame': 'During hospitalization', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 8 months', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 3 Years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death', 'timeFrame': '0 to 5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': 'During hospitalization', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 8 months', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 1 year', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 2 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 3 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 4 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With MI Related to Target Vessel', 'timeFrame': '0 to 5 years', 'description': 'Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\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': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': 'During hospitalization', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 8 months', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 1 year', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 2 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 3 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 4 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)', 'timeFrame': '0 to 5 years', 'description': 'DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': 'During hospitalization', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 8 months', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 1 year', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 2 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 3 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 4 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With All Revascularization', 'timeFrame': '0 to 5 years', 'description': 'All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.'}, {'measure': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': 'During hospitalization', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 8 months', 'description': 'Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).'}, {'measure': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 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': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 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': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 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': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 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': 'Number of Participants With Target Vessel Failure (TVF)', 'timeFrame': '0 to 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': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': 'During hospitalization', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 8 months', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 1 year', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 2 years', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 3 years', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 4 years', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (Non-TLR)', 'timeFrame': '0 to 5 years', 'description': 'Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': 'During hospitalization', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 8 months', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 1 year', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 2 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 3 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 4 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))', 'timeFrame': '0 to 5 years', 'description': 'Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': 'During hospitalization', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 8 months', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 1 year', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 2 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 3 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 4 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)', 'timeFrame': '0 to 5 years', 'description': 'Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': 'During hospitalization', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 8 months', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 1 year', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 2 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 3 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 4 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Death/All MI', 'timeFrame': '0 to 5 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': 'During hospitalization', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 8 months', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 1 year', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 2 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 3 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 4 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death/All MI', 'timeFrame': '0 to 5 years', 'description': 'All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.\n\nVascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.\n\nNon-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.\n\nMyocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.\n\n-Non-Q wave MI: Those MIs which are not Q-wave MI'}, {'measure': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': 'During hospitalization', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 8 months', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 1 year', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 2 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 3 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 4 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Cardiac Death or Target-Vessel MI', 'timeFrame': '0 to 5 years', 'description': 'Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (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': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': 'During hospitalization', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 8 months', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 1 year', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 2 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 3 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 4 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Number of Participants With Target Lesion Failure (TLF)', 'timeFrame': '0 to 5 years', 'description': 'TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).'}, {'measure': 'Mean Acute Gain: In-stent, In-segment', 'timeFrame': 'At 8 months, post index procedure', 'description': 'The difference between post- and pre-procedural MLD.'}, {'measure': 'Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal', 'timeFrame': 'At 8 months, post index procedure', 'description': 'Late loss is calculated as MLD post procedure - MLD at follow-up.'}, {'measure': 'Mean Net Gain: In-stent, In-segment', 'timeFrame': 'At 8 months, post index procedure', 'description': 'Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).'}, {'measure': 'Mean Lesion Length', 'timeFrame': 'Pre-procedure', 'description': 'The lesion length will be measured by QCA.'}, {'measure': 'Minimum Blood Vessel Diameter', 'timeFrame': 'Pre-procedure', 'description': 'Minimum blood vessel diameter measured by QCA'}, {'measure': 'Minimum Blood Vessel Diameter', 'timeFrame': 'Immediately after the procedure', 'description': 'Minimum blood vessel diameter measured by QCA'}, {'measure': 'Minimum Blood Vessel Diameter', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'Minimum blood vessel diameter measured by QCA'}, {'measure': 'Mean Reference Vessel Diameter (RVD)', 'timeFrame': 'Pre-procedure', 'description': 'Reference vessel diameter measured by QCA'}, {'measure': 'Mean Reference Vessel Diameter (RVD)', 'timeFrame': 'Immediately after the procedure', 'description': 'Reference vessel diameter measured by QCA'}, {'measure': 'Mean Reference Vessel Diameter (RVD)', 'timeFrame': 'During follow-up, at 8 months post procedure', 'description': 'Reference vessel diameter measured by QCA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug Eluting Stent', 'Coronary Stent', 'Everolimus', 'Stent Thrombosis'], 'conditions': ['Ischemic Heart Disease', 'Angina Pectoris', 'Coronary Artery Disease', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.', 'detailedDescription': 'Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.\n\nThe XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE Xpedition 2.25 mm stent will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion criteria\n\n 1. Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.\n 2. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.\n\n * The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.\n * A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.\n * The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.\n * Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.\n * A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.\n2. Exclusion criteria\n\n 1. If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.\n 2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.\n3. A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.'}, 'identificationModule': {'nctId': 'NCT02513732', 'briefTitle': 'XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance', 'orgStudyIdInfo': {'id': '14-306'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'XIENCE Xpedition 2.25 mm stent arm', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent', 'interventionNames': ['Device: XIENCE Xpedition 2.25 mm stent']}], 'interventions': [{'name': 'XIENCE Xpedition 2.25 mm stent', 'type': 'DEVICE', 'description': 'Patients receiving XIENCE Xpedition 2.25 mm stent', 'armGroupLabels': ['XIENCE Xpedition 2.25 mm stent arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '660-0828', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Prefectural Amagasaki Hospital', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '920-8530', 'city': 'Ishikawa', 'country': 'Japan', 'facility': 'Ishikawa Prefectural Central Hospital', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'zip': '880-0834', 'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Miyazaki Medical Association Hospital', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '543-0035', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Police Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '062-0003', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hanaoka Seishu Memorial Cardiovascular Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-8618', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'JCHO Hokkaido Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '773-8502', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'Tokushima Red Cross Hospital', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '101-8643', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Mitsui Memorial Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '105-8470', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '173-8606', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Teikyo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '227-8501', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Showa University Fujigaoka Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Ken Kozuma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Teikyo University Hospital, Tokyo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}