Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-05 @ 7:29 PM
Study NCT ID:
NCT01575808
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2012-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-center Study for Stent Graft System for Peripheral Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'takohki@msn.com', 'phone': '81-090-2478-8304', 'title': 'Dr. Takao Ohki', 'organization': 'Toyko Jikei University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse events were systematically reported on Case Report Forms', 'eventGroups': [{'id': 'EG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft', 'otherNumAtRisk': 103, 'otherNumAffected': 41, 'seriousNumAtRisk': 103, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hypertension aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Angina pectoris aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Anginal attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Atrial fibrillation paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Non-sustained ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Bilateral cataracts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cataract aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Left cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Right cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Acute gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Haemorrhage of digestive tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Right inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Small intestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Arterial stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hepatic function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Allergic reaction to antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Acute pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Influenza A virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cataract operation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chronic subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'In-stent coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'In-stent peripheral artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Malleolar fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Peripheral artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Poisoning by hypnotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'CRP increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Potassium abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sugar blood level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Insulin hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Loss of control of blood sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Malignant neoplasm of lateral wall of oropharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Renal failure chronic aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Interstitial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Assisted Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '91', 'ciLowerLimit': '86.3', 'groupDescription': 'A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'One-sided z-test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Primary Efficacy Endpoint \\>\n\n\\> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Duration of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft'}, {'id': 'OG001', 'title': 'Retrospective Surgical Bypass Outcomes', 'description': 'Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to discharge', 'description': 'Duration (in days) of post-procedure hospital stay', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Avoidance of General Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft'}, {'id': 'OG001', 'title': 'Retrospective Surgical Bypass Outcomes', 'description': 'Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96.5', 'ciUpperLimit': '100', 'estimateComment': 'Confidence interval calculated with binomial exact method.', 'groupDescription': 'The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Percentage of study subjects avoiding general anesthesia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96.5', 'ciUpperLimit': '100.0', 'estimateComment': 'Confidence intervals calculated using the binomial exact method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Composite endpoint of 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'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Not Experiencing an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown', 'unitOfMeasure': 'percent of 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[{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'No bypass surgery and no occlusion at the target site', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'No bypass surgery and no occlusion at the target site', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'timeFrame': '24 months', 'description': 'No bypass surgery and no occlusion at the target site', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'X-ray for stent fracture evaluated by Core Lab', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'X-ray for stent fracture evaluated by Core Lab', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'X-ray for stent fracture evaluated by Core Lab', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'X-ray for stent fracture evaluated by Core Lab', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '24 months', 'description': 'X-ray for stent fracture evaluated by Core Lab', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Avoidance of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Avoidance of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Avoidance of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Avoidance of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'Probability of having an event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Kaplan-Meier estimate done at end of follow-up visit window'}, {'type': 'SECONDARY', 'title': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.1', 'ciLowerLimit': '91.7', 'ciUpperLimit': '99.4', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'timeFrame': '24 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '0.118', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),', 'unitOfMeasure': 'ABI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.137', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)', 'unitOfMeasure': 'ABI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '0.137', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)', 'unitOfMeasure': 'ABI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '0.171', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)', 'unitOfMeasure': 'ABI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Vascular Quality of Life Questionnaire - VascuQOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Quality of Life Questionnaire - VascuQOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '1.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Quality of Life Questionnaire - VascuQOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '1.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Quality of Life Questionnaire - VascuQOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '1.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '24 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire-WIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '34.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire-WIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '34.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire-WIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '34.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire-WIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '34.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '24 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Rate of Avoidance of Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft\\>\n\n\\> GP1101: Endovascular stent graft implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '96.5', 'ciUpperLimit': '100.0', 'estimateComment': 'Confidence Interval calculated with binomial exact method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GP1101', 'description': 'Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \\>\n\n\\> GP1101: Endovascular Device Implantation'}, {'id': 'FG001', 'title': 'Retrospective Surgical Bypass Outcomes', 'description': 'Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Study ongoing. All 103 assessed for primary invasiveness endpoints,100 for primary efficacy endpoint', 'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft'}, {'id': 'BG001', 'title': 'Retrospective Surgical Bypass Outcomes', 'description': 'Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '72.3', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '161.9', 'spread': '8.48', 'groupId': 'BG000'}, {'value': '161.9', 'spread': '8.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Height was not measured in the Retrospective Surgical Bypass Outcomes arm'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.2', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '10.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Weight was not measured in the Retrospective Surgical Bypass Outcomes arm'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '2.83', 'groupId': 'BG000'}, {'value': '22.5', 'spread': '2.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/㎡', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI was not measured in the Retrospective Surgical Bypass Outcomes arm'}, {'title': 'Smoking History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current Smoker', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Not a Current Smoker', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Diabetes Mellitus = Yes', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'History of Diabetes Mellitus = No', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Hypertension = Yes', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'History of Hypertension = No', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Dyslipidemia = Yes', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'History of Dyslipidemia = No', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Carotid Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Carotid Disease = Yes', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'History of Carotid Disease = No', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary Artery Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Coronary Artery Disease = Yes', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'History of Coronary Artery Disease = No', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Myocardial Infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Myocardial Infarction = Yes', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'History of Myocardial Infarction - No', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of Congestive Heart Failure = Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'HIstory of Congestive Heart Failure = No', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'History of COPD = Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'History of COPD = No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Limb', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Right', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Left', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ankle Brachial Index (ABI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '0.47', 'spread': '0.20', 'groupId': 'BG001'}, {'value': '0.57', 'spread': '0.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Eligibility met by TBI for one subject.'}, {'title': 'Rutherford Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Category 0 - Asymptomatic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Category 1 - Mild Claudication', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Category 2 - Moderate Claudication', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Category 3 - Severe Claudication', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Category 4 - Ischemic Rest Pain', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Category 5 - Minor Tissue Loss', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Category 6- Major Tissue Loss', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2012-04-09', 'resultsFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2012-04-10', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-26', 'studyFirstPostDateStruct': {'date': '2012-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Assisted Patency', 'timeFrame': '12 months', 'description': 'Primary Efficacy Endpoint \\>\n\n\\> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion'}, {'measure': 'Duration of Stay', 'timeFrame': 'Up to discharge', 'description': 'Duration (in days) of post-procedure hospital stay'}, {'measure': 'Rate of Avoidance of General Anesthesia', 'timeFrame': 'Day 0', 'description': 'Percentage of study subjects avoiding general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)', 'timeFrame': '1 month', 'description': 'Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '1 month', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '3 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '6 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '12 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '24 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '36 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Percent of Participants Not Experiencing an Adverse Event', 'timeFrame': '48 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Rate of Avoidance of Adverse Events', 'timeFrame': '60 months', 'description': '% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown'}, {'measure': 'Technical Success', 'timeFrame': 'Post-procedure', 'description': 'Placement of GP1101 with residual stenosis of less than 30%'}, {'measure': 'Primary Patency', 'timeFrame': '1 month', 'description': 'Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization'}, {'measure': 'Primary Patency', 'timeFrame': '3 months', 'description': 'Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization'}, {'measure': 'Primary Patency', 'timeFrame': '6 months', 'description': 'Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization'}, {'measure': 'Primary Patency', 'timeFrame': '12 months', 'description': 'Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization'}, {'measure': 'Primary Patency', 'timeFrame': '24 months', 'description': 'Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization'}, {'measure': 'Secondary Patency', 'timeFrame': '1 month', 'description': 'No bypass surgery and no occlusion at the target site'}, {'measure': 'Secondary Patency', 'timeFrame': '3 months', 'description': 'No bypass surgery and no occlusion at the target site'}, {'measure': 'Secondary Patency', 'timeFrame': '6 months', 'description': 'No bypass surgery and no occlusion at the target site'}, {'measure': 'Secondary Patency', 'timeFrame': '12 months', 'description': 'No bypass surgery and no occlusion at the target site'}, {'measure': 'Secondary Patency', 'timeFrame': '24 months', 'description': 'No bypass surgery and no occlusion at the target site'}, {'measure': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '1 month', 'description': 'X-ray for stent fracture evaluated by Core Lab'}, {'measure': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '3 months', 'description': 'X-ray for stent fracture evaluated by Core Lab'}, {'measure': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '6 months', 'description': 'X-ray for stent fracture evaluated by Core Lab'}, {'measure': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '12 months', 'description': 'X-ray for stent fracture evaluated by Core Lab'}, {'measure': 'Rate of Avoidance of Stent Fracture', 'timeFrame': '24 months', 'description': 'X-ray for stent fracture evaluated by Core Lab'}, {'measure': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '1 month'}, {'measure': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '3 months'}, {'measure': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '6 months'}, {'measure': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '12 months'}, {'measure': 'Avoidance of Target Lesion Revascularization', 'timeFrame': '24 months'}, {'measure': 'Clinical Success', 'timeFrame': '1 month', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.'}, {'measure': 'Clinical Success', 'timeFrame': '3 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.'}, {'measure': 'Clinical Success', 'timeFrame': '6 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.'}, {'measure': 'Clinical Success', 'timeFrame': '12 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.'}, {'measure': 'Clinical Success', 'timeFrame': '24 months', 'description': 'The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene\n\nThe percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.'}, {'measure': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),'}, {'measure': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)'}, {'measure': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)'}, {'measure': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)'}, {'measure': 'Change in Ankle-Brachial Index From Baseline', 'timeFrame': 'Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented', 'description': 'Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)'}, {'measure': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '1 month', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.'}, {'measure': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '3 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.'}, {'measure': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '6 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.'}, {'measure': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '12 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.'}, {'measure': 'Vascular Quality of Life Questionnaire - VascuQOL', 'timeFrame': '24 months', 'description': 'VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.'}, {'measure': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '1 month', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.'}, {'measure': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '3 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.'}, {'measure': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '6 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.'}, {'measure': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '12 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.'}, {'measure': 'Walking Impairment Questionnaire-WIQ', 'timeFrame': '24 months', 'description': 'WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.'}, {'measure': 'Rate of Avoidance of Blood Transfusion', 'timeFrame': 'Post-Procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Symptomatic PAD', 'Stenosis', 'Occlusion'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '34182032', 'type': 'DERIVED', 'citation': 'Ohki T, Kichikawa K, Yokoi H, Iida O, Yamaoka T, Maeda K, Kanaoka Y. Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery. J Vasc Surg. 2021 Dec;74(6):1958-1967.e2. doi: 10.1016/j.jvs.2021.05.056. Epub 2021 Jun 26.'}, {'pmid': '28400218', 'type': 'DERIVED', 'citation': 'Ohki T, Kichikawa K, Yokoi H, Uematsu M, Yamaoka T, Maeda K, Kanaoka Y. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg. 2017 Jul;66(1):130-142.e1. doi: 10.1016/j.jvs.2017.01.065. Epub 2017 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Rutherford 2-5 category\n* Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).\n* At least 20 years of age.\n* Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5.\n* Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.\n* Projected life expectancy of greater than 2 years.\n* The ability to comply with the study protocol, follow-up requirements and required testing.\n* Surgical bypass candidate\n* Qualifying lesions by angiography\n\nExclusion Criteria:\n\n* Untreated flow-limiting aortoiliac disease.\n* Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).\n* Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.\n* Planned surgery or intervention within 30 days after study procedure.\n* Femoral artery or popliteal artery aneurysm \\> 1.5 X healthy adjacent vessel diameter.\n* Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).\n* Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)\n* Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.\n* Rutherford 5 patients with active infection.\n* Serum creatinine \\>2.5 mg/dL within 30 days prior to study procedure.\n* Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.\n* Rutherford 5 characteristics in non-study limb.\n* Major distal amputation (above the transmetatarsal) in the study or non-study limb.\n* Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.\n* Any previously known coagulation disorder, including hypercoagulability.\n* Morbid obesity or operative scarring that precludes percutaneous approach\n* Contraindication to anticoagulation or antiplatelet\n* Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.\n* Current peritoneal or hemodialysis\n* Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.\n* Enrollment in a F/P device clinical trial within the last 12 months.\n* Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.\n* Any other factor identified by the Principal Investigator"}, 'identificationModule': {'nctId': 'NCT01575808', 'acronym': 'VJH11-01', 'briefTitle': 'Multi-center Study for Stent Graft System for Peripheral Artery', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'JPS 16-02 / VJH11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP1101', 'description': 'Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft', 'interventionNames': ['Device: GP1101']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective Surgical Bypass Outcomes', 'description': 'Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion werer established to be consistent with the experimental arm.'}], 'interventions': [{'name': 'GP1101', 'type': 'DEVICE', 'otherNames': ['Gore VIABAHN Endoprosthesis'], 'description': 'Endovascular stent graft implantation', 'armGroupLabels': ['GP1101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagano', 'state': 'Asahi, Matsumoto', 'country': 'Japan', 'facility': 'Shinshu University Hospital', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Matsuyama Red Cross Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '802-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '060-0031', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Tokeidai Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '660-8511', 'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kansai Rousai Hospital', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe University Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '651-0053', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe Rosai Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '663-8501', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo College of Medicine Hospital', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '920-8650', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'National Hospital Organaization Kanazawa Medical Center', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '980-0873', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Sendai Kousei Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '596-8522', 'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kishiwada Tokushukai Hospital', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '634-8522', 'city': 'Nara', 'country': 'Japan', 'facility': 'Nara Medical University Hospital', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Jikei Medical University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Takao Ohki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jikei Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}