Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-05-29 @ 12:17 PM
Study NCT ID:
NCT03421561
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ILLUMENATE Pivotal Post-Approval Study (PAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicolas.aguirre@philips.com', 'phone': '612-297-6655', 'title': 'Nicolas Aguirre', 'organization': 'Philips'}, 'certainAgreement': {'otherDetails': 'Research Institution and PI shall have the right to publish, present or otherwise publicly disclose the results to their own activity conducted in the trial. Proposals must be submitted to the sponsor for review 30 days prior to publishing submission. Sponsor has the right to require confidentially sensitive information be removed (not including results) and/or delay publication for an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up.', 'description': 'The definitions are the same.', 'eventGroups': [{'id': 'EG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 192, 'seriousNumAtRisk': 200, 'deathsNumAffected': 34, 'seriousNumAffected': 177}, {'id': 'EG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 95, 'seriousNumAtRisk': 100, 'deathsNumAffected': 19, 'seriousNumAffected': 85}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 20, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 55, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LOCAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY RESTENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 64, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 29, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 37, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FEMORAL ARTERY DISSECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INTERMITTENT CLAUDICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 124, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 56, 'numAffected': 35}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 98, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 63, 'numAffected': 34}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypchromic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nephrogenic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 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100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis Erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal Angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 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(19.0)'}, {'term': 'TOXICITY TO VARIOUS AGENTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'VASCULAR GRAFT COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'VASCULAR GRAFT OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'VASCULAR PSEUDOANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'WOUND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'WRIST FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'TROPONIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIABETIC COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIABETIC KETOACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FAILURE TO THRIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FLUID OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'GOUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOVOLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MALNUTRITION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CERVICAL SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': "DUPUYTREN'S CONTRACTURE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MOBILITY DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SYNOVIAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'TENDONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ADENOCARCINOMA OF THE CERVIX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BLADDER CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BONE NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CERVIX CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CERVIX CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'COLON ADENOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HEPATOCELLULAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LARYNGEAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LUNG CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'METASTATIC MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'NEOPLASM PROSTATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OESOPHAGEAL ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SALIVARY GLAND NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SMALL CELL LUNG CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SPLENIC NEOPLASM MALIGNANCY UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SQUAMOUS CELL CARCINOMA OF LUNG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CAROTID ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CARPAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CEREBROVASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CERVICAL MYELOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DYSARTHRIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HAEMORRHAGE INTRACRANIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HEMIPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYDROCEPHALUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'IVTH NERVE PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'POSTICTAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'STATUS EPILEPTICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SUBARACHNOID HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'UNRESPONSIVE TO STIMULI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ALCOHOL ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DEPENDENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ACUTE PRERENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RENAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RENAL FAILURE CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'URINARY TRACT INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BENIGN PROSTATIC HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ERECTILE DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ACUTE RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BRONCHITIS CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infected Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pasteurella Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ANGIOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DECUBITUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ANGIOPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'AORTIC VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'CATARACT OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'KNEE ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'OBESITY SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY ANGIOPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary Tract Infection Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Viral Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY BYPASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL REVASCULARISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'RESECTION OF RECTUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'TOE AMPUTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'WOUND DRAINAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ACCELERATED HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BLUE TOE SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FEMORAL ARTERY DISSECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FEMORAL ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INTERMITTENT CLAUDICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 59, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY DISSECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 64, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 42, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'THROMBOPHLEBITIS SUPERFICIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'VARICOSE VEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'VENOUS INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Target Vessel Patency at 24 Months Post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patency was defined as absence of target lesion restenosis (as assessed by the duplex ultrasound core laboratory based on PSVR ≤ 2.5) and CD-TLR through 24 months (defined as 730 ± 45 days, i.e., up to 775 days) or angiographic core laboratory assessment of restenosis. Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject was considered a failure if they experienced device or procedure-related death within 30 days, or if they experienced target limb major amputation or CD-TLR within 24 months (defined as 730 ± 45 days, i.e., up to 775 days). Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Vessel Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Vessel Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Vessel Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Target Vessel Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Limb Major Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Limb Major Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Limb Major Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Target Limb Major Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-brachial Index (ABI) From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-brachial Index (ABI) From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Walking Distance From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Walking Distance From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford-Becker Classification From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.\n\nCategory Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease\n\nMild claudication Moderate claudication Severe claudication 4\\*-Ischemic rest pain 5\\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \\*Categories 4, 5, and 6 are also described as critical limb ischemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford-Becker Classification From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.\n\nCategory Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease\n\nMild claudication Moderate claudication Severe claudication 4\\*-Ischemic rest pain 5\\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \\*Categories 4, 5, and 6 are also described as critical limb ischemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in EQ-5D Index From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post-procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in EQ-5D Index From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months post-procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in EQ-5D VAS From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months post procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}, {'type': 'SECONDARY', 'title': 'Change in EQ-5D VAS From Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'OG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 month post procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'FG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '30'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.\n\nStellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.'}, {'id': 'BG001', 'title': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.\n\nEverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '68.8', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all participants reported this demographic information.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': 'NA', 'comment': 'Native Hawaiian or Pacific Islander was not collected.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Native Hawaiian or Pacific Islander was not collected.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': 'More than one race was not collected.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'More than one race was not collected.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all participants reported this demographic.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ankle-Brachial Index', 'classes': [{'title': 'Ankle-Brachial Index Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.21', 'groupId': 'BG000'}, {'value': '0.76', 'spread': '0.20', 'groupId': 'BG001'}, {'value': '0.75', 'spread': '0.21', 'groupId': 'BG002'}]}]}, {'title': 'Non-Compressible', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Non-compressible does not return a measurement, no value is available.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Non-compressible does not return a measurement, no value is available.', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.'}, {'title': 'Rutherford-Becker Clinical Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'RCC 2', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'RCC 3', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'RCC 4', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral Vascular Disease (PVD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hyperlipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Myocardial Infarction (MI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Angina Pectoris', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure (CHF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Percutaneous or Surgical Coronary Revascularization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal Insufficiency', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Liver Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cerebrovascular Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Obstructive Pulmonary Occlusion (COPD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Deep Vein Thrombosis (DVT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes (Total)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes - Type I', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes - Type II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Previous or Current Smoker', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Intervention of the Lower Limb', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Intervention of the Study Limb', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-14', 'size': 1178810, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-08T15:23', 'hasProtocol': True}, {'date': '2016-09-01', 'size': 1079476, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-10T14:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2018-01-23', 'resultsFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-08', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Target Vessel Patency at 24 Months Post-procedure', 'timeFrame': '24 months post-procedure', 'description': 'Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.'}, {'measure': 'Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure', 'timeFrame': '24 months post-procedure', 'description': 'The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '24 months post-procedure', 'description': 'Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).'}, {'measure': 'Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '36 months post-procedure', 'description': 'Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).'}, {'measure': 'Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '48 months post-procedure', 'description': 'Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).'}, {'measure': 'Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '60 months post-procedure', 'description': 'Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).'}, {'measure': 'Rate of Clinically-driven Target Lesion Revascularization', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.'}, {'measure': 'Rate of Clinically-driven Target Lesion Revascularization', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.'}, {'measure': 'Rate of Clinically-driven Target Lesion Revascularization', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.'}, {'measure': 'Rate of Clinically-driven Target Lesion Revascularization', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \\>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.'}, {'measure': 'Rate of Target Lesion Revascularization', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee'}, {'measure': 'Rate of Target Lesion Revascularization', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee'}, {'measure': 'Rate of Target Lesion Revascularization', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee'}, {'measure': 'Rate of Target Lesion Revascularization', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee'}, {'measure': 'Rate of Clinically-driven Target Vessel Revascularization', 'timeFrame': '24 months post-procedure', 'description': 'Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.'}, {'measure': 'Rate of Clinically-driven Target Vessel Revascularization', 'timeFrame': '36 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.'}, {'measure': 'Rate of Clinically-driven Target Vessel Revascularization', 'timeFrame': '48 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.'}, {'measure': 'Rate of Clinically-driven Target Vessel Revascularization', 'timeFrame': '60 months post-procedure', 'description': 'Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \\>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.'}, {'measure': 'Rate of Target Limb Major Amputation', 'timeFrame': '24 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb'}, {'measure': 'Rate of Target Limb Major Amputation', 'timeFrame': '36 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb'}, {'measure': 'Rate of Target Limb Major Amputation', 'timeFrame': '48 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb'}, {'measure': 'Rate of Target Limb Major Amputation', 'timeFrame': '60 months post-procedure', 'description': 'Number of subjects in which a major amputation occurred in the target limb'}, {'measure': 'Mortality Rate', 'timeFrame': '24 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period'}, {'measure': 'Mortality Rate', 'timeFrame': '36 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period'}, {'measure': 'Mortality Rate', 'timeFrame': '48 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period'}, {'measure': 'Mortality Rate', 'timeFrame': '60 months post-procedure', 'description': 'Number of subject who have died during the post-procedure follow up period'}, {'measure': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'timeFrame': '24 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment'}, {'measure': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'timeFrame': '36 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment'}, {'measure': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'timeFrame': '48 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment'}, {'measure': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'timeFrame': '60 months post-procedure', 'description': 'Rate of occurrence of arterial thrombosis of the treated segment'}, {'measure': 'Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR', 'timeFrame': '24 months post-procedure', 'description': 'Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR'}, {'measure': 'Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR', 'timeFrame': '36 months post-procedure', 'description': 'Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR'}, {'measure': 'Change in Ankle-brachial Index (ABI) From Pre-procedure', 'timeFrame': '24 months post-procedure', 'description': 'The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.'}, {'measure': 'Change in Ankle-brachial Index (ABI) From Pre-procedure', 'timeFrame': '36 months post-procedure', 'description': 'The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.'}, {'measure': 'Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure', 'timeFrame': '24 months post-procedure', 'description': 'A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication'}, {'measure': 'Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure', 'timeFrame': '36 months post-procedure', 'description': 'A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication'}, {'measure': 'Change in Walking Distance From Pre-procedure', 'timeFrame': '24 months post-procedure', 'description': 'Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.'}, {'measure': 'Change in Walking Distance From Pre-procedure', 'timeFrame': '36 months post-procedure', 'description': 'Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.'}, {'measure': 'Change in Rutherford-Becker Classification From Pre-procedure', 'timeFrame': '24 months post-procedure', 'description': 'Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.\n\nCategory Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease\n\nMild claudication Moderate claudication Severe claudication 4\\*-Ischemic rest pain 5\\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \\*Categories 4, 5, and 6 are also described as critical limb ischemia.'}, {'measure': 'Change in Rutherford-Becker Classification From Pre-procedure', 'timeFrame': '36 months post-procedure', 'description': 'Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.\n\nCategory Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease\n\nMild claudication Moderate claudication Severe claudication 4\\*-Ischemic rest pain 5\\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \\*Categories 4, 5, and 6 are also described as critical limb ischemia.'}, {'measure': 'Change in EQ-5D Index From Pre-procedure', 'timeFrame': '24 months post-procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.'}, {'measure': 'Change in EQ-5D Index From Pre-procedure', 'timeFrame': '36 months post-procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.'}, {'measure': 'Change in EQ-5D VAS From Pre-procedure', 'timeFrame': '24 months post procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion'}, {'measure': 'Change in EQ-5D VAS From Pre-procedure', 'timeFrame': '36 month post procedure', 'description': 'EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '31567024', 'type': 'DERIVED', 'citation': 'Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.', 'detailedDescription': 'The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.\n\nEach enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E\n\nStudy subjects must fulfill the following clinical criteria:\n\n1. Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.\n2. Greater than or equal to 18 years of age.\n3. Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.\n4. Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).\n5. Life expectancy \\>1 year.\n6. Rutherford-Becker classification of 2, 3 or 4.\n\n Study Subjects must fulfill the following angiographic criteria:\n7. De novo or restenotic lesion (except for in-stent restenotic lesion) \\>70% within the SFA and/or popliteal artery in a single limb.\n8. Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.\n9. Lesion is treatable by no more than two (2) study devices.\n10. Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.\n11. Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).\n12. Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \\<30% without death or major vascular complication.\n13. Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.\n\nExclusion Criteria -\n\nSubject with any of the following clinical criteria should be excluded:\n\n1. Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.\n2. Known aortic aneurysm(s) \\> 5 cm.\n3. Contraindication to dual anti-platelet therapy.\n4. Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.\n5. Current participation in an investigational drug or another device study.\n6. History of hemorrhagic stroke within 3 months.\n7. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).\n8. Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.\n9. Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.\n10. Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.\n11. Chronic renal insufficiency (dialysis dependent, or serum creatinine \\>2.5 mg/dL within 30 days of index procedure).\n\n Subject with any of the following angiographic criteria should be excluded:\n12. Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.\n13. No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.\n14. Known inadequate distal outflow.\n15. Acute or sub-acute thrombus in the target vessel.\n16. Aneurysmal target vessel.\n17. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.\n18. Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).\n19. Presence of concentric calcification that precludes PTA pre-dilation.\n20. Prior stent placement in the target vessel.\n21. Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.'}, 'identificationModule': {'nctId': 'NCT03421561', 'briefTitle': 'ILLUMENATE Pivotal Post-Approval Study (PAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectranetics Corporation'}, 'officialTitle': 'ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon Pivotal Post-Approval Study', 'orgStudyIdInfo': {'id': 'D035940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCB Subjects', 'description': 'The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater than or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.', 'interventionNames': ['Device: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PTA Subjects', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).\n\nBasic Catheter Specifications\n\n* Guidewire: 0.035"\n* Balloon Length: 40/80/120 mm\n* Sheath Compatibility: greater to or equal to 6 French\n* Balloon Diameter: 4/5/6 mm\n* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.', 'interventionNames': ['Device: EverCross™ 0.035 PTA Balloon Catheter']}], 'interventions': [{'name': 'Stellarex 0.035" OTW Drug-coated Angioplasty Balloon', 'type': 'DEVICE', 'description': 'The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.', 'armGroupLabels': ['DCB Subjects']}, {'name': 'EverCross™ 0.035 PTA Balloon Catheter', 'type': 'DEVICE', 'description': 'The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).', 'armGroupLabels': ['PTA Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United 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{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health & Research Education Institution', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Cardiology Associates', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Clinical Trial Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 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