Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT03241459
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore', 'Switzerland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khawkinson@surmodics.com', 'phone': '952-500-7563', 'title': 'Kimberly Hawkinson', 'organization': 'Surmodics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Enrollment through 60-months', 'eventGroups': [{'id': 'EG000', 'title': 'Surmodics SurVeil DCB', 'description': 'Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.\n\nSurmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 159, 'seriousNumAtRisk': 222, 'deathsNumAffected': 41, 'seriousNumAffected': 166}, {'id': 'EG001', 'title': 'Medtronic IN.PACT Admiral DCB', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.\n\nMedtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 170, 'seriousNumAtRisk': 224, 'deathsNumAffected': 37, 'seriousNumAffected': 162}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adrenal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eyelid dermatochalasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ocular vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal drusen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinopathy hypertensive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitreous adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oesophageal squamous cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinonasal papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms 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{'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epidural lipomatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 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20.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Genital erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ovarian mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Unassigned'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neuropathic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic intramural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arterial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Penetrating aortic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 64, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 50, 'numAffected': 35}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Subclavian steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Venous stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Lesion Patency Though 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '87.9'}, {'value': '85.9', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '91.0'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-3.7', 'ciLowerLimit': '-11.7', 'pValueComment': 'P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.', 'estimateComment': 'For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.', 'groupDescription': 'The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \\[DUS\\] peak systolic velocity ratio \\[PSVR\\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis of the primary effectiveness endpoint was carried out on all randomized participants. For participants missing primary effectiveness endpoint status (48 for SurVeil DCB and 31 for IN.PACT Admiral DCB), a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.'}, {'type': 'PRIMARY', 'title': 'Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '95.6'}, {'value': '89.8', 'groupId': 'OG001', 'lowerLimit': '85.8', 'upperLimit': '93.8'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '2.0', 'ciLowerLimit': '-4.1', 'pValueComment': 'P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.', 'estimateComment': 'For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.', 'groupDescription': 'The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Multiple Imputation was carried out on Intention-to-Treat (ITT) subjects. For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surmodics SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': "P-value is derived from two-sided Fisher's exact test.", 'groupDescription': "The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of \\<50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography \\[QA\\]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.", 'groupDescription': "The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Defined as achievement of a final residual diameter stenosis of \\<50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) Analysis Population with quantitative angiography completed by an angiography core lab.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "P-value is derived from two-sided Fisher's exact test.", 'groupDescription': "The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) Analysis Population'}, {'type': 'SECONDARY', 'title': 'Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.494', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "P-value is derived from two-sided Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Population with assessments/follow-up completed through 30 days and/or subjects who experienced the endpoint (or any of its components) were included in the analysis (i.e., counted in the denominator).'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Primary Lesion Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.9', 'ciLowerLimit': '-12.1', 'pValueComment': 'P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.', 'groupDescription': 'The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was carried out on ITT subjects with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Target Vessel Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Target Vessel Patency at 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'Target Vessel Patency at 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.699', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '12-Month P-Value', 'groupDescription': 'The main analysis of the secondary endpoints will be carried out using the ITT analysis set.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '24-Month P-Value', 'groupDescription': 'The main analysis of the secondary endpoints will be carried out using the ITT analysis set.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months, 24 months', 'description': 'Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) analysis population with available data (i.e., subjects who experienced CD-TLR through 790 days and/or binary restenosis through 24 months, or had at least 670 days of follow-up).'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Sustained Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': '6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': '12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': '24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.699', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': '6-Month P-Value', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.447', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '12-Month P-Value', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.589', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '24-Month P-Value', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Clinically-driven TLR at 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Clinically-driven TLR at 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Clinically-driven TLR at 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 6-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.823', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 12-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.454', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 24-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Historical Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Historical MAEs at 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Historical MAEs at 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Historical MAEs at 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.535', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 6-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 12-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.390', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 24-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Major Target Limb Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Major Target Limb Amputation at 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Major Target Limb Amputation at 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Major Target Limb Amputation at 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 24-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 730 days for 24-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Thrombosis at the Target Lesion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Thrombosis at Target Lesion at 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis at Target Lesion at 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis at Target Lesion at 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.472', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 24-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 30 days for 1-month time point, 180 days for 6-month time point, 365 days for 12-month time point, 760 days for 24-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Target Limb Rutherford Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Change in Rutherford Classification from Baseline to 1-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Grade ≥+3 Markedly improved', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}, {'title': 'Grade +2 Moderately improved', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Grade +1 Mildly improved', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Grade -1 Mildly worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade -2 Moderately worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade ≤-3 Markedly worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in Rutherford Classification from Baseline to 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Grade ≥+3 Markedly improved', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}, {'title': 'Grade +2 Moderately improved', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'title': 'Grade +1 Mildly improved', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Grade -1 Mildly worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade -2 Moderately worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade ≤-3 Markedly worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change in Rutherford Classification from Baseline to 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Grade ≥+3 Markedly improved', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'title': 'Grade +2 Moderately improved', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'title': 'Grade +1 Mildly improved', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Grade -1 Mildly worsening', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Grade -2 Moderately worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade ≤-3 Markedly worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change in Rutherford Classification from Baseline to 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Grade ≥+3 Markedly improved', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Grade +2 Moderately improved', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Grade +1 Mildly improved', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Grade -1 Mildly worsening', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Grade -2 Moderately worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Grade ≤-3 Markedly worsening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in Rutherford Classification from BL to 1-Month', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in Rutherford Classification from BL to 6-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in Rutherford Classification from BL to 12-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in Rutherford Classification from BL to 24-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, and 24 months', 'description': 'Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months.\n\nRutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria.\n\nPossible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows:\n\n0 - Asymptomatic - no hemodynamically significant occlusive disease\n\n1. \\- Mild claudication\n2. \\- Moderate claudication\n3. \\- Severe claudication\n4. \\- Ischemic rest pain\n5. \\- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia\n6. \\- Major tissue loss, extending above transmetatarsal) with all scores defined as follows:\n\nChange = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom Rutherford classification was available at the respective timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Target Limb Peripheral Academic Research Consortium (PARC) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Change in PARC class from BL to 1-Month: Grade ≥+3 Markedly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade +2 Moderately improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade +1 Mildly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade 0 No change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade -1 Mildly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade -2 Moderately worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC class from BL to 1-Month: Grade ≤-3 Markedly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade ≥+3 Markedly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade +2 Moderately improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade +1 Mildly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade 0 No change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade -1 Mildly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade -2 Moderately worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 6-Months: Grade ≤-3 Markedly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade ≥+3 Markedly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade +2 Moderately improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade +1 Mildly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade 0 No change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade -1 Mildly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade -2 Moderately worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Class from BL to 12-Months: Grade ≤-3 Markedly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade ≥+3 Markedly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade +2 Moderately improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade +1 Mildly improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade 0 No change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade -1 Mildly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade -2 Moderately worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in PARC Classification from BL to 24-Months: Grade ≤-3 Markedly worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.320', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in PARC from BL to 1-Month', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.132', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in PARC from BL to 6-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in PARC from BL to 12-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.194', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for change in PARC from BL to 24-Months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, 1 month, 6 months, 12 months, and 24 months', 'description': 'Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.\n\nPARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD).\n\nPossible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following:\n\nAsymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping \\> 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping \\< 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene\n\nChange =', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom PARC clinical classification was available at the respective timepoint.'}, {'type': 'SECONDARY', 'title': 'Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'BL to 6-Months: Decrease in Resting Target Limb ABI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'BL to 6-Months: Decrease in Resting Target Limb TBI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BL to 12-Months: Decrease in Resting Target Limb ABI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'BL to 12-Months: Decrease in Resting Target Limb TBI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'BL to 24-Months: Decrease in Resting Target Limb ABI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'BL to 24-Months: Decrease in Resting Target Limb TBI ≥0.15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.789', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.401', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, 6 months, 12 months, and 24 months', 'description': 'Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months.\n\nAnkle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.\n\nToe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery.\n\nif ABI could not be assessed, TBI could be used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the secondary endpoint includes the Intention-to-Treat analysis population for whom the ABI or TBI was available at the respective timepoint. Worsening of ABI was defined as a decrease in ABI ≥0.15 from baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Walking Impairment Questionnaire (WIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Change from BL to 1-Month: Walking Impairment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '75.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '75.0'}]}]}, {'title': 'Change from BL to 1-Month: Walking Distance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '70.3'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '65.0'}]}]}, {'title': 'Change from BL to 1-Month: Walking Speed Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '43.5'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '34.8'}]}]}, {'title': 'Change from BL to 1-Month: Stair Climbing Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '54.2'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.8'}]}]}, {'title': 'Change from BL to 12-Months: Walking Impairment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '75.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '75.0'}]}]}, {'title': 'Change from BL to 12-Months: Walking Distance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '62.9'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '66.9'}]}]}, {'title': 'Change from BL to 12-Months: Walking Speed Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '43.5'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '43.5'}]}]}, {'title': 'Change from BL to 12-Months: Stair Climbing Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '47.9'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '54.2'}]}]}, {'title': 'Change from BL to 24-Months: Walking Impairment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '75.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '75.0'}]}]}, {'title': 'Change from BL to 24-Months: Walking Distance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '61.8'}, {'value': '27.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '65.1'}]}]}, {'title': 'Change from BL to 24-Months: Walking Speed Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '40.8'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '39.1'}]}]}, {'title': 'Change from BL to 24-Months: Stair Climbing Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '45.8'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.8'}]}]}], 'analyses': [{'pValue': '0.995', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 1-Month: Walking Impairment Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 1-month: Walking distance score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.695', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 1-month: Walking speed score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 1-Month: Stair Climbing Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.331', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 12-Months: Walking Impairment Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.580', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 12-Months: Walking Distance Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 12-Months: Walking Speed Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.270', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 12-Months: Stair Climbing Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 24-Months: Walking Impairment Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ from BL to 24-Months: Walking Distance Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ for BL to 24-Months: Walking Speed Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in WIQ for BL to 24-Months: Stair Climbing Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening, 1 month, 12 months, and 24 months', 'description': 'Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population for whom Walking Impairment Questionnaire information was available from Baseline to each respective time point.\n\nAn increase in a WIQ score signifies improvement.'}, {'type': 'SECONDARY', 'title': 'Change in 6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Change from BL to 12-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.8', 'spread': '118.8', 'groupId': 'OG000'}, {'value': '60.7', 'spread': '113.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from BL to 24-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.7', 'spread': '98.8', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '122.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.237', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in 6MWT from BL to 12-Months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in 6MWT from BL to 24-Months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Screening, 12 months, and 24 months', 'description': 'Change in 6MWT from baseline to 12 and 24 months.', 'unitOfMeasure': 'Distance walked (meters)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat population for whom the 6-Minute Walk Test information from Baseline to each respective time point was available.'}, {'type': 'SECONDARY', 'title': 'Change in Peripheral Artery Questionnaire (PAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': '1-Month: Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '58.3'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '50.0'}]}]}, {'title': '1-Month: Stability Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '50.0'}]}]}, {'title': '1-Month: Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '52.8'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '50.0'}]}]}, {'title': '1-Month: Treatment Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '16.7'}]}]}, {'title': '1-Month: Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '58.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '50.0'}]}]}, {'title': '1-Month: Social Limitation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '50.0'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '50.0'}]}]}, {'title': '1-Month: Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '52.8'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '46.6'}]}]}, {'title': '12-Months: Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '45.8'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '54.2'}]}]}, {'title': '12-Months: Stability Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '25.0'}]}]}, {'title': '12-Months: Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '47.2'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '52.8'}]}]}, {'title': '12-Months: Treatment Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.3', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}, {'title': '12-Months: Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '58.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '58.3'}]}]}, {'title': '12-Months: Social Limitation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '50.0'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '58.3'}]}]}, {'title': '12-Months: Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '49.1'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '52.8'}]}]}, {'title': '24-Months: Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '50.0'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '54.2'}]}]}, {'title': '24-Month: Stability Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '25.0'}]}]}, {'title': '24-Months: Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '50.0'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '52.8'}]}]}, {'title': '24-Months: Treatment Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.3'}]}]}, {'title': '24-Months: Quality of Life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '58.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '58.3'}]}]}, {'title': '24-Months: Social Limitation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '50.0'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '50.0'}]}]}, {'title': '24-Months: Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '48.3'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '49.9'}]}]}], 'analyses': [{'pValue': '0.772', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Physical Function Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.930', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Stability Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Symptom Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.621', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Quality of Life Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.592', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Social Limitation Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.601', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 1-Month: Summary Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Physical Function Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.856', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Stability Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.541', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Symptom Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.731', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.696', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Quality of Life Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.716', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Social Limitation Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.797', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months: Summary Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.290', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Physical Function Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.473', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Stability Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Symptom Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.974', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Quality of Life Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.656', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 24-Months: Social Limitation Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.959', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for change in PAQ from BL to 12-Months:Summary Score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening, 1 month, 12 months, and 24 months', 'description': 'The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat Analysis Population for whom the PAQ score information from baseline to each respective time point was available.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Clinically-driven TLR at 36-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Clinically-driven TLR at 486-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Clinically-driven TLR at 60-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 36-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.903', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 48-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 60-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48-month time point,1825 days for 60-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Historical Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Historical MAEs at 36-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Historical MAEs at 48-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Historical MAEs at 60-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.913', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-Value at 36-Months'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-Value at 48-Months'}, {'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 60-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Major Target Limb Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Major Target Limb Amputation at 36-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Major Target Limb Amputation at 48-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Major Target Limb Amputation at 60-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 36-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-Value at 48-Months'}, {'pValue': '0.251', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-Value at 60-Months'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Thrombosis at the Target Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SurVeil DCB', 'description': 'Participants randomized to receive treatment with the SurVeil DCB.'}, {'id': 'OG001', 'title': 'IN.PACT Admiral DCB', 'description': 'Participants randomized to receive treatment with the IN.PACT Admiral DCB.'}], 'classes': [{'title': 'Thrombosis at Target Lesion at 36-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis at Target Lesion at 48-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis at Target Lesion at 60-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 36-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.605', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 48-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value at 60-Months', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat analysis population consisting of participants either experiencing the event within the period (e.g., 1095 days for 36-month time point, 1460 days for 48--month time point, 1825 days for 60-month time point) or who have adequate follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surmodics SurVeil DCB', 'description': 'Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.\n\nSurmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.'}, {'id': 'FG001', 'title': 'Medtronic IN.PACT Admiral DCB', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.\n\nMedtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '1-Month Visit (30 Days, - 2 to +15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '6-Month Visit (180 Days +/- 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '12-Month Visit (365 Days +/- 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': '24-Month Visit (730 Days +/- 60 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Subjects with symptomatic PAD presenting for percutaneous revascularization of stenosed femoral and/or popliteal arteries (either de novo lesions or non-stented restenotic lesions \\>90 days from prior POBA angioplasty or \\>180 days from prior DCB treatment) will be screened according to the protocol inclusion and exclusion criteria. Enrolled subjects who have met all the clinical inclusion criteria and none of the clinical exclusion criteria will then be screened for angiographic criteria.', 'preAssignmentDetails': 'Subjects screened via angiographic assessment to confirm remaining study eligibility prior to randomization. Subjects not meeting criteria were considered screen failures and exited from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Surmodics SurVeil DCB', 'description': 'Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.\n\nSurmodics SurVeil DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.'}, {'id': 'BG001', 'title': 'Medtronic IN.PACT Admiral DCB', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.\n\nMedtronic IN.PACT Admiral DCB: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 2351092, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-21T09:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 446}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2021-09-08', 'completionDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2017-08-01', 'resultsFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2017-08-02', 'dispFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Lesion Patency Though 12 Months', 'timeFrame': '12 months', 'description': 'Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \\[DUS\\] peak systolic velocity ratio \\[PSVR\\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.'}, {'measure': 'Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)', 'timeFrame': '12 months', 'description': 'Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Device Success', 'timeFrame': 'Day 0', 'description': 'Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of \\<50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography \\[QA\\]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device.'}, {'measure': 'Proportion of Participants With Technical Success', 'timeFrame': 'Day 0', 'description': 'Defined as achievement of a final residual diameter stenosis of \\<50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.'}, {'measure': 'Proportion of Participants With Procedure Success', 'timeFrame': '72 hours', 'description': 'Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.'}, {'measure': 'Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days', 'timeFrame': '30 days', 'description': 'Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.'}, {'measure': 'Proportion of Participants With Primary Lesion Patency', 'timeFrame': '24 months', 'description': 'Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).'}, {'measure': 'Proportion of Participants With Target Vessel Patency', 'timeFrame': '12 months, 24 months', 'description': 'Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.'}, {'measure': 'Proportion of Participants With Sustained Clinical Improvement', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.'}, {'measure': 'Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.'}, {'measure': 'Proportion of Participants With a Historical Major Adverse Events (MAEs)', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.'}, {'measure': 'Proportion of Participants With a Major Target Limb Amputation', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.'}, {'measure': 'Proportion of Participants With a Thrombosis at the Target Lesion.', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.'}, {'measure': 'Change in Target Limb Rutherford Class', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, and 24 months', 'description': 'Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months.\n\nRutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria.\n\nPossible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows:\n\n0 - Asymptomatic - no hemodynamically significant occlusive disease\n\n1. \\- Mild claudication\n2. \\- Moderate claudication\n3. \\- Severe claudication\n4. \\- Ischemic rest pain\n5. \\- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia\n6. \\- Major tissue loss, extending above transmetatarsal) with all scores defined as follows:\n\nChange = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores'}, {'measure': 'Change in Target Limb Peripheral Academic Research Consortium (PARC) Class', 'timeFrame': 'Screening, 1 month, 6 months, 12 months, and 24 months', 'description': 'Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.\n\nPARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD).\n\nPossible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following:\n\nAsymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping \\> 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping \\< 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene\n\nChange ='}, {'measure': 'Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)', 'timeFrame': 'Screening, 6 months, 12 months, and 24 months', 'description': 'Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months.\n\nAnkle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.\n\nToe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery.\n\nif ABI could not be assessed, TBI could be used.'}, {'measure': 'Change in Walking Impairment Questionnaire (WIQ)', 'timeFrame': 'Screening, 1 month, 12 months, and 24 months', 'description': 'Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.'}, {'measure': 'Change in 6-Minute Walk Test (6MWT)', 'timeFrame': 'Screening, 12 months, and 24 months', 'description': 'Change in 6MWT from baseline to 12 and 24 months.'}, {'measure': 'Change in Peripheral Artery Questionnaire (PAQ)', 'timeFrame': 'Screening, 1 month, 12 months, and 24 months', 'description': 'The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity.'}, {'measure': 'Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.'}, {'measure': 'Proportion of Participants With a Historical Major Adverse Events (MAEs)', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.'}, {'measure': 'Proportion of Participants With a Major Target Limb Amputation', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.'}, {'measure': 'Proportion of Participants With a Thrombosis at the Target Lesion', 'timeFrame': '36 months, 48 months, 60 months', 'description': 'Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Percutaneous Transluminal Angioplasty', 'PTA', 'Peripheral Artery Disease', 'PAD', 'Paclitaxel'], 'conditions': ['Peripheral Arterial Disease', 'Peripheral Vascular Disease', 'Artery Disease, Peripheral', 'Femoropopliteal Artery Occlusion']}, 'referencesModule': {'references': [{'pmid': '16549646', 'type': 'BACKGROUND', 'citation': 'Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.'}, {'pmid': '17140820', 'type': 'BACKGROUND', 'citation': 'Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.'}, {'pmid': '26476467', 'type': 'BACKGROUND', 'citation': 'Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.'}, {'pmid': '26106946', 'type': 'BACKGROUND', 'citation': 'Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.'}, {'pmid': '25744011', 'type': 'BACKGROUND', 'citation': 'Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036.'}, {'pmid': '39615582', 'type': 'DERIVED', 'citation': "Brodmann M, Gray WA, Schneider PA, Kurzmann-Guetl K, Schweiger L, Zeller T, Thieme M, Kilaru S, Bachinsky WB, Feldman RL, Holden A, Varcoe RL, Lansky AJ, Rosenfield K; TRANSCEND Study Investigators. Editor's Choice - Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: 24 Month Outcomes of the Randomised TRANSCEND Study. Eur J Vasc Endovasc Surg. 2025 Mar;69(3):452-462. doi: 10.1016/j.ejvs.2024.11.351. Epub 2024 Nov 29."}, {'pmid': '30685679', 'type': 'DERIVED', 'citation': 'Elmariah S, Ansel GM, Brodmann M, Doros G, Fuller S, Gray WA, Pinto DS, Rosenfield KA, Mauri L. Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery - the TRANSCEND study. Am Heart J. 2019 Mar;209:88-96. doi: 10.1016/j.ahj.2018.12.012. Epub 2018 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.', 'detailedDescription': 'TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥18 years.\n* Subject has target limb Rutherford classification 2, 3 or 4.\n* Subject has provided written informed consent and is willing to comply with study follow-up requirements.\n* De novo lesion(s) or non-stented restenotic lesion(s) occurring \\>90 days after prior plain old balloon (POBA) angioplasty or \\>180 days after prior DCB treatment.\n* Target lesion location starts ≥10 mm below the common femoral bifurcation and terminates distally at or above the end of the P1 segment of the popliteal artery.\n* Target vessel diameter ≥4 mm and ≤7 mm.\n* Target lesion must have angiographic evidence of ≥70% stenosis by operator visual estimate.\n* Chronic total occlusions may be included only after successful, uncomplicated wire crossing of target lesion via an anterograde approach and without the use of subintimal dissection techniques.\n* Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: combination lesions must have a total lesion length of ≤180 mm by visual estimate and be separated by ≤30 mm.\n* Target lesion is located at least 30 mm from any stent, if target vessel was previously stented.\n* Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen.\n* After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow limiting dissection and treatable with available device matrix.\n* A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.\n* At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.\n\nExclusion Criteria:\n\n* Subject has acute limb ischemia.\n* Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using plain old balloon angioplasty (POBA) or a stent within the previous 90 days.\n* Subject underwent any lower extremity percutaneous treatment using a paclitaxel-eluting stent or a DCB within the previous 90 days.\n* Subject underwent PTA of the target lesion using a DCB within the previous 180 days.\n* Subject has had prior vascular intervention in the contralateral limb within 14 days before the planned study index procedure or subject has planned vascular intervention in the contralateral limb within 30 days after the index procedure.\n* Subject is pregnant, breast-feeding or intends to become pregnant during the time of the study.\n* Subject has life expectancy less than 2 years.\n* Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.\n* Subject is allergic to ALL antiplatelet treatments.\n* Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL).\n* Subject is dialysis dependent.\n* Subject is receiving immunosuppressant therapy.\n* Subject has known or suspected active infection at the time of the index procedure.\n* Subject has platelet count \\<100,000/mm3 or \\>700,000/mm3.\n* Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure.\n* Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).\n* Subject has history of stroke within the past 90 days.\n* Subject has a history of myocardial infarction within the past 30 days.\n* Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.\n* Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.\n* Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study.\n* Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.\n* Subject had previous bypass surgery of the target lesion.\n* Subject had previous treatment of the target vessel with thrombolysis or surgery.\n* Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.\n* Target lesion has severe calcification (as defined by the PARC classification of calcification).\n* Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).\n* Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection techniques.\n* Significant target vessel tortuosity or other parameters prohibiting access to the target lesion.\n* Presence of thrombus in the target vessel.\n* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications.\n* Presence of an aortic, iliac or femoral artificial graft.'}, 'identificationModule': {'nctId': 'NCT03241459', 'acronym': 'TRANSCEND', 'briefTitle': 'Safety and Efficacy of the SurVeil™ Drug-Coated Balloon', 'organization': {'class': 'INDUSTRY', 'fullName': 'SurModics, Inc.'}, 'officialTitle': 'Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB', 'orgStudyIdInfo': {'id': 'SUR17-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surmodics SurVeil DCB', 'description': 'Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.', 'interventionNames': ['Device: Surmodics SurVeil DCB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medtronic IN.PACT Admiral DCB', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.', 'interventionNames': ['Device: Medtronic IN.PACT Admiral DCB']}], 'interventions': [{'name': 'Surmodics SurVeil DCB', 'type': 'DEVICE', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.', 'armGroupLabels': ['Surmodics SurVeil DCB']}, {'name': 'Medtronic IN.PACT Admiral DCB', 'type': 'DEVICE', 'description': 'Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.', 'armGroupLabels': ['Medtronic IN.PACT Admiral DCB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiovascular Associates of the Southeast', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology Associates', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dignity Health', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Yuma Regional Medical Center', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Mission Cardiovascular Research Institute', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34478', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Insitute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital (Clifton)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Medical Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Health', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education (PERC)', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St Vincent Heart (Research Department)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Endovascular Technologies, LLC', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Associates Research', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Northern Michigan Hospital', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'North Memorial Hospital', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Hattiesburg Clinic', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Medical Group, P.A.', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. 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