Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-03 @ 6:27 AM
Study NCT ID:
NCT05734157
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krista.stiefel@abbott.com', 'phone': '+12246689359', 'title': 'Krista Stiefel, Principal Clinical Scientist', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 51, 'seriousNumAtRisk': 75, 'deathsNumAffected': 3, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CRP increase at discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Irregular heartrate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thoracic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Burning pain in esophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Esophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Allergy to medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angiography performed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bruises easily', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bruising/hemotoma over body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Calf claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Calf pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Deep vein thrombosis, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diabetes mellitus II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Distal arteriopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizzyness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Groin bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Groin/scrotum hematoma (non-study limb)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haematoma, right arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haematoma, wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Knee injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leg claudication, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leg oedema, both legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower body/limbs hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower leg swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Necrosectomy, heel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Polyneuropathy, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, non-TL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Swollen knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'TL occlusion, no action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Teeth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tingling/numbing foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Toe pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Covid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'AV fistula post-dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bleeding at groin puncture site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Distal embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Groin pain at puncture site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hematoma at puncture site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain in lower leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Perforation from guidewire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Superficial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Disc prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sciatica pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal canal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chronic kidney insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Skin tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Death during heart surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Partial Infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Right ventricular implant repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colon tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Inflammatory bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Terminal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aneurysm spurium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Distal embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal contusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': "Parkinson's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, non-study limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, non-study vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, non-target lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stenosis, target vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasal resection (squamous cell cancer)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Glaucoma surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'PRIMARY', 'title': 'The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post procedure', 'description': 'Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Major Adverse Event (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In Hospital', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). The time frame for "In hospital" refers to time from procedure to discharge. This timeframe is different for every enrolled subject. The subject is discharged at the treating physician\'s discretion based on their specific treatment needs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Major Adverse Event (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days Post-procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Major Adverse Event (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months Post-procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12months', 'description': 'Rate of occurrence arterial thrombosis of the treated segment as determined by QVA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Ipsilateral Embolic Events of the Study Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'This end point was to asses the Rate of Clinically-driven Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of Clinically-driven Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'This end point was to asses the Rate of Clinically-driven Revascularization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis.'}, {'type': 'SECONDARY', 'title': 'Patency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Rate of Vascular Access Site Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Lesion Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \\<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Technical success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \\<50% (by QA), using the CVT Everolimus-coated PTA Catheter without a device malfunction after wire passage through the lesion. Pre- and postdilatation are considered part of assigned device treatment.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Discharge', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Ankle-Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Pre procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.0', 'spread': '36.9', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '35.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on degree of difficulty, according to approximate number of feet, stairs, or miles per hour for distance, stair-climbing, and speed scores, respectively. Scores are then divided by maximum number of points and presented on a scale of 0% to 100%, where 0% represents lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less difficulty with walking, while a lower score signifies greater difficulty with walking.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Pre procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '16.7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '31.5', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '31.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). Higher scores signify less difficulty in maintaining speed while walking.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Pre procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': '17.6', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '17.8', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'spread': '12.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less perceived walking impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.'}, {'type': 'SECONDARY', 'title': 'Walking Test: Change in Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '231.3', 'spread': '93.6', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '382.8', 'spread': '151.7', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '399.6', 'spread': '138.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months and 12 months', 'description': 'The Walking Test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.'}, {'type': 'SECONDARY', 'title': 'Treadmill Test: Change in Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.9', 'spread': '52.8', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '104.0', 'spread': '72.7', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106.0', 'spread': '74.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months and 12 months', 'description': 'Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Class 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Class 3', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Class 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Class 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Class 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-procedure', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Class 0', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Class 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Class 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Class 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Class 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Change in Rutherford Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'classes': [{'title': 'Class 0', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Class 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Class 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Class 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Class 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Class 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus-coated Balloon', 'description': 'The Chansu Vascular Technologies (CVT) Everolimus-coated PTA Catheter is an angioplasty catheter designed to facilitate percutaneous treatment of subjects with documented symptomatic occlusion and/or \\>70% stenosis of the SFA or popliteal (P1 segment) artery.\n\nThe CVT Everolimus-coated PTA Catheter is comprised of two main components:\n\n1. A CE-marked, commercially-available PTA balloon catheter designed to treat peripheral vascular artery lesions. The PTA catheters are also previously cleared by FDA for peripheral (PTA) angioplasty indications.\n2. A drug coating comprised of an approved, commercially-available active pharmaceutical agent (API) mixed with an approved commercially-available excipi Theent. active pharmaceutical agent is the drug everolimus, in crystalline form, and it is applied onto the balloon using a glycerol ester excipient. Everolimus, like sirolimus, is an mTOR inhibitor drug with cytostatic properties. Everolimus is currently used in CE mark and FDA approved coronary drug-eluting stents \\[Promus (Boston Scientific), Xience (Abbott Vascular), Synergy (Boston Scientific)\\].'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Telephone call', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total seventy-five (75) subjects were enrolled in the CVT-SFA study at eight (8) investigational sites in Europe between February 17, 2022, and September 01, 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus-coated Balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-02', 'size': 1433056, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-25T01:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2023-01-27', 'resultsFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-21', 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate', 'timeFrame': '6 months post procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).'}, {'measure': 'The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)', 'timeFrame': '6 months post procedure', 'description': 'Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Rate of Major Adverse Event (MAE)', 'timeFrame': 'In Hospital', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). The time frame for "In hospital" refers to time from procedure to discharge. This timeframe is different for every enrolled subject. The subject is discharged at the treating physician\'s discretion based on their specific treatment needs.'}, {'measure': 'Rate of Major Adverse Event (MAE)', 'timeFrame': '30 Days Post-procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).'}, {'measure': 'Rate of Major Adverse Event (MAE)', 'timeFrame': '12 months Post-procedure', 'description': 'Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).'}, {'measure': 'Rate of Occurrence of Arterial Thrombosis of the Treated Segment', 'timeFrame': '12months', 'description': 'Rate of occurrence arterial thrombosis of the treated segment as determined by QVA'}, {'measure': 'Rate of Ipsilateral Embolic Events of the Study Limb', 'timeFrame': '12 months', 'description': 'This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.'}, {'measure': 'Rate of Clinically-driven Revascularization', 'timeFrame': '6 months', 'description': 'This end point was to asses the Rate of Clinically-driven Revascularization.'}, {'measure': 'Rate of Clinically-driven Revascularization', 'timeFrame': '12 months', 'description': 'This end point was to asses the Rate of Clinically-driven Revascularization.'}, {'measure': 'Patency Rate', 'timeFrame': '12 months', 'description': 'The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.'}, {'measure': 'Rate of Vascular Access Site Complication', 'timeFrame': '12 months', 'description': 'Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.'}, {'measure': 'Lesion Success', 'timeFrame': '12 months', 'description': 'Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \\<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.'}, {'measure': 'Technical Success', 'timeFrame': '12 months', 'description': 'Technical success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \\<50% (by QA), using the CVT Everolimus-coated PTA Catheter without a device malfunction after wire passage through the lesion. Pre- and postdilatation are considered part of assigned device treatment.'}, {'measure': 'Clinical Success', 'timeFrame': '12 months', 'description': 'Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.'}, {'measure': 'Procedural Success', 'timeFrame': '12 months', 'description': 'Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.'}, {'measure': 'Change in Ankle-Brachial Index (ABI)', 'timeFrame': 'Discharge', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.'}, {'measure': 'Change in Ankle-Brachial Index (ABI)', 'timeFrame': '6 months', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.'}, {'measure': 'Change in Ankle-Brachial Index (ABI)', 'timeFrame': '12 months', 'description': 'Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.'}, {'measure': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on degree of difficulty, according to approximate number of feet, stairs, or miles per hour for distance, stair-climbing, and speed scores, respectively. Scores are then divided by maximum number of points and presented on a scale of 0% to 100%, where 0% represents lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less difficulty with walking, while a lower score signifies greater difficulty with walking.'}, {'measure': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). Higher scores signify less difficulty in maintaining speed while walking.'}, {'measure': 'Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment', 'timeFrame': 'Pre-Procedure to 6 months and 12 months', 'description': 'The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person\'s walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less perceived walking impairment.'}, {'measure': 'Walking Test: Change in Walking Distance', 'timeFrame': 'Baseline to 6 months and 12 months', 'description': 'The Walking Test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'Treadmill Test: Change in Walking Distance', 'timeFrame': 'Baseline to 6 months and 12 months', 'description': 'Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': 'Pre-procedure', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': '6 months', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': '12 months', 'description': 'Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings.\n\nClass 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \\> 50 mm Hg but at least 20 mm Hg lower than resting value.\n\nClass 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \\< 50 mm Hg.\n\nClass 4 critical limb ischemia resting AP \\< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \\< 30 mm Hg.\n\nClass 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \\< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \\< 40 mm Hg. The lower the RB Class the better the outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TP1109', 'CVT-SFA', 'Femoral Artery Stenosis'], 'conditions': ['Femoral Artery Stenosis', 'Popliteal Artery Stenosis', 'Femoral Artery Occlusion', 'Popliteal Artery Occlusion']}, 'descriptionModule': {'briefSummary': 'The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.', 'detailedDescription': 'The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must be at least 18 years of age.\n2. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.\n3. Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.\n4. Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.\n5. De novo or restenotic lesion(s) \\>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area.\n6. Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.\n7. Successful wire crossing of lesion.\n8. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).\n9. Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.\n10. At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.\n11. Life expectancy \\>1 year\n12. Rutherford classification of 2, 3 or 4.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females.\n2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.\n3. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.\n4. Known intolerance to study medications, everolimus or contrast agents.\n5. Doubts in the willingness or capability of the subject to allow follow-up examinations.\n6. Subject is actively participating in another investigational device or drug study.\n7. History of hemorrhagic stroke within 3 months of procedure.\n8. Previous or planned surgical or interventional procedure within 30 days of index procedure.\n9. Prior vascular surgery of the target lesion.\n10. Lesion length is \\<3 cm or \\>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.\n11. Known inadequate distal outflow.\n12. Significant inflow disease.\n13. Acute or sub-acute thrombus in target vessel.\n14. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).\n15. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.\n16. Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.\n17. Rutherford classification of 0, 1, 5 or 6\n18. Presence of prohibitive calcification that precludes adequate PTA treatment.\n19. Subjects held in custody in an institution by official or court order.'}, 'identificationModule': {'nctId': 'NCT05734157', 'briefTitle': 'CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation', 'orgStudyIdInfo': {'id': 'TP1109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus-coated balloon', 'description': 'Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.', 'interventionNames': ['Device: Peripheral PTA with a drug coated balloon']}], 'interventions': [{'name': 'Peripheral PTA with a drug coated balloon', 'type': 'DEVICE', 'description': 'Peripheral artery angioplasty', 'armGroupLabels': ['Everolimus-coated balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83190', 'city': 'Ollioules', 'country': 'France', 'facility': 'Polyclinique Les Fleurs', 'geoPoint': {'lat': 43.1399, 'lon': 5.84766}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Hôpital Nord Laennec - CHU de Nantes', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Institut für Radiologie, Kinderradiologie und interventionelle Therapie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Jüdisches Krankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '24939', 'city': 'Flensburg', 'country': 'Germany', 'facility': 'DIAKO Krankenhaus Flensburg', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'zip': '83022', 'city': 'Rosenheim', 'country': 'Germany', 'facility': 'Romed Klinikum Rosenheim', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}