Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02542267
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-Stent Restenosis Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'enovak@wlgore.com', 'phone': '314-440-2119', 'title': 'Eric Novak', 'organization': 'W. L. Gore & Associates'}, 'certainAgreement': {'otherDetails': 'Institution and Investigator agree not to submit any Publication until Study Completion and the multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and Investigator may be able to proceed with submission of the Publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 30, 'seriousNumAtRisk': 108, 'deathsNumAffected': 13, 'seriousNumAffected': 70}], 'otherEvents': [{'term': 'In-stent arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Atrial fibrillation with rapid ventricular response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Atrioventricular junctional escape rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Congestive cardiac failure aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Decompensation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Non ST segment elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Non STEMI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Paroxysmal atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Triple vessel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Unstable angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Colon stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Esophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Lower gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Retroperitoneal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Delayed healing of wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'In-stent arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'In-stent arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Unknown cause of death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Wound healing delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Bile duct stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Bilateral pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cellulitis genital organ (male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cellulitis of leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Gangrene peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Infectious diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Influenza A virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Influenza B virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Osteomyelitis of the foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Broken bones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Drug overdose accidental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Fractured hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Malignant neoplasm of hypopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Urothelial carcinoma urethra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cerebral infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Grand mal seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hemiparesis (left)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Internal carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Near syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Subarachnoid hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Tremor aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute retention of urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute on chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Chronic obstructive airways disease exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Chronic obstructive pulmonary disease exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoxic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary necrotizing granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Foot ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Critical limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.715', 'groupId': 'OG000', 'lowerLimit': '0.607', 'upperLimit': '0.797'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During hospitalization, approximately 1-2 days', 'description': 'Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Patency at 30 Days and 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '30 Day', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.932', 'upperLimit': '0.999'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '0.715', 'groupId': 'OG000', 'lowerLimit': '0.607', 'upperLimit': '0.797'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '0.561', 'groupId': 'OG000', 'lowerLimit': '0.448', 'upperLimit': '0.661'}]}]}, {'title': '36 Month', 'categories': [{'measurements': [{'value': '0.449', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '0.558'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Assisted Patency at 30 Days and 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '30 Day', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '0.772', 'groupId': 'OG000', 'lowerLimit': '0.669', 'upperLimit': '0.846'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '0.643', 'groupId': 'OG000', 'lowerLimit': '0.529', 'upperLimit': '0.736'}]}]}, {'title': '36 Month', 'categories': [{'measurements': [{'value': '0.556', 'groupId': 'OG000', 'lowerLimit': '0.434', 'upperLimit': '0.662'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Patency at 30 Days and 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '30 Day', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '0.929', 'groupId': 'OG000', 'lowerLimit': '0.849', 'upperLimit': '0.967'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '0.822', 'groupId': 'OG000', 'lowerLimit': '0.718', 'upperLimit': '0.891'}]}]}, {'title': '36 Month', 'categories': [{'measurements': [{'value': '0.732', 'groupId': 'OG000', 'lowerLimit': '0.608', 'upperLimit': '0.822'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '30 Day', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '0.828', 'groupId': 'OG000', 'lowerLimit': '0.738', 'upperLimit': '0.890'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '0.746', 'groupId': 'OG000', 'lowerLimit': '0.645', 'upperLimit': '0.823'}]}]}, {'title': '36 Month', 'categories': [{'measurements': [{'value': '0.668', 'groupId': 'OG000', 'lowerLimit': '0.558', 'upperLimit': '0.756'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '30 Day', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}, {'title': '36 Month', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '0.679', 'spread': '0.176', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'categories': [{'measurements': [{'value': '1.004', 'spread': '0.133', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 Days', 'categories': [{'measurements': [{'value': '0.325', 'spread': '0.205', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 30 Days', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 30 days.'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '0.693', 'spread': '0.164', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.921', 'spread': '0.188', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 Year', 'categories': [{'measurements': [{'value': '0.229', 'spread': '0.235', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 1 Year', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 1 year.'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '0.700', 'spread': '0.159', 'groupId': 'OG000'}]}]}, {'title': '2 Years', 'categories': [{'measurements': [{'value': '0.913', 'spread': '0.187', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 Years', 'categories': [{'measurements': [{'value': '0.213', 'spread': '0.227', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 2 Years', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 2 Years.'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '0.708', 'spread': '0.162', 'groupId': 'OG000'}]}]}, {'title': '3 Years', 'categories': [{'measurements': [{'value': '0.937', 'spread': '0.174', 'groupId': 'OG000'}]}]}, {'title': 'Change at 3 Years', 'categories': [{'measurements': [{'value': '0.229', 'spread': '0.231', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 3 Years', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 3 Years.'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Category at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 Days', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 30 Days', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Rutherford Category measured at both pre-procedure and 30 days.'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Category at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 Year', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 1 Year', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Rutherford Category measured at both pre-procedure and 1 year.'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Category at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 Years', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 2 Years', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Rutherford Category measured at both pre-procedure and 2 years.'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Category at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at 3 Years', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure and 3 Years', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects with Rutherford Category measured at both pre-procedure and 3 years.'}, {'type': 'SECONDARY', 'title': 'Stent Fracture at 12, 24, and 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'classes': [{'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '36 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12, 24, and 36 months', 'description': 'Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who had x-ray or angiographic data to determine device stent fracture at the reported corresponding follow-up time period..'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Surgical Bypass of All Study Devices', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery\n\nGore VIABAHN Endoprosthesis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race only collected among U.S. study subjects.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rutherford Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Category 0', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Category 1', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Category 2', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Category 3', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Category 4', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Category 5', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Category 6', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6):\n\nCategory 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Participants'}, {'title': 'Ankle Brachial Index (ABI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.670', 'spread': '0.177', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values range from 0 to \\>1, with smaller values indicating more severe obstruction and larger values indicating better blood flow.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing or unknown/not measured.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-10', 'size': 968190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-15T09:33', 'hasProtocol': True}, {'date': '2015-05-01', 'size': 571404, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-15T09:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2015-08-19', 'resultsFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness', 'timeFrame': '12 Months', 'description': 'Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.'}, {'measure': 'Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure', 'timeFrame': '30 Days', 'description': 'Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Acute Procedural Success', 'timeFrame': 'During hospitalization, approximately 1-2 days', 'description': 'Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.'}, {'measure': 'Primary Patency at 30 Days and 12, 24, and 36 Months', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.'}, {'measure': 'Primary Assisted Patency at 30 Days and 12, 24, and 36 Months', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.'}, {'measure': 'Secondary Patency at 30 Days and 12, 24, and 36 Months', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.'}, {'measure': 'Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.'}, {'measure': 'Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months', 'timeFrame': '30 days and 12, 24, and 36 months', 'description': 'Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.'}, {'measure': 'Change in Ankle Brachial Index at 30 Days', 'timeFrame': 'Pre-procedure and 30 Days', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.'}, {'measure': 'Change in Ankle Brachial Index at 1 Year', 'timeFrame': 'Pre-procedure and 1 Year', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.'}, {'measure': 'Change in Ankle Brachial Index at 2 Years', 'timeFrame': 'Pre-procedure and 2 Years', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.'}, {'measure': 'Change in Ankle Brachial Index at 3 Years', 'timeFrame': 'Pre-procedure and 3 Years', 'description': 'The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values \\<= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and \\>1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.'}, {'measure': 'Change in Rutherford Category at 30 Days', 'timeFrame': 'Pre-procedure and 30 Days', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.'}, {'measure': 'Change in Rutherford Category at 1 Year', 'timeFrame': 'Pre-procedure and 1 Year', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.'}, {'measure': 'Change in Rutherford Category at 2 Years', 'timeFrame': 'Pre-procedure and 2 Years', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.'}, {'measure': 'Change in Rutherford Category at 3 Years', 'timeFrame': 'Pre-procedure and 3 Years', 'description': 'The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.'}, {'measure': 'Stent Fracture at 12, 24, and 36 Months', 'timeFrame': '12, 24, and 36 months', 'description': 'Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bare Metal Stent', 'In-Stent Restenosis'], 'conditions': ['Peripheral Artery Disease', 'Vascular Disease']}, 'descriptionModule': {'briefSummary': 'The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a previously implanted (\\> 30 days) non-covered stent(s) located in the SFA\n* Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)\n* Patient demonstrates an Ankle Brachial Index (ABI) \\<=0.9. If ABI \\>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \\<=0.5\n* Patient has \\>=50% in-stent restenosis and / or an occlusion in a previously implanted (\\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.\n* Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease\n* Patient has a reference vessel diameter between 4.0 and 6.5mm\n* Patient has at least one patent infrapopliteal runoff vessel (\\<50% stenosis) not requiring reintervention\n* Note: Additional Inclusion Criteria may apply\n\nExclusion Criteria:\n\n* Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)\n* Patient has a known intolerance to anticoagulation or antiplatelet therapy\n* Patient has known coagulation disorder, including hypercoagulability.\n* Patient has major distal amputation (above the transmetatarsal)\n* Patient has any previous surgery in the target vessel\n* Patient has had previous target vessel in-stent restenosis treated by relining with another stent\n* Patient has untreated flow-limiting aortoiliac stenotic disease\n* Note: Additional Exclusion Criteria may apply'}, 'identificationModule': {'nctId': 'NCT02542267', 'briefTitle': 'In-Stent Restenosis Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)', 'orgStudyIdInfo': {'id': 'ISR 14-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gore VIABAHN Endoprosthesis', 'description': 'Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery', 'interventionNames': ['Device: Gore VIABAHN Endoprosthesis']}], 'interventions': [{'name': 'Gore VIABAHN Endoprosthesis', 'type': 'DEVICE', 'armGroupLabels': ['Gore VIABAHN Endoprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Foundation Hospital', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford CardioVascular Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Covenant Medical Center, Inc.', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Munson Medical Center', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '64116', 'city': 'North Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Aortic and Vascular Institute (MAVI)', 'geoPoint': {'lat': 39.13, 'lon': -94.56218}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital/Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Heart and Vascular', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Health', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Heart Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16502', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Vincent's Consultants in Cardiovascular Disease", 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Research - Presbyterian Heart and Vascular', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Research - Presbyterian Hospital of Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center - Heart and Vascular Research', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Area Medical Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'city': 'Rosenheim', 'country': 'Germany', 'facility': 'Klinikum Rosenheim', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skånes Universitetssjukhus', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Peter Soukas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miriam Hospital, Providence, RI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}