Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-17 @ 7:12 PM
Study NCT ID:
NCT01667393
Status:
WITHDRAWN
Last Update Posted:
2019-04-17
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2013-01'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency', 'timeFrame': '12 months', 'description': 'Primary efficacy will be target lesion primary patency at 12 months.'}], 'secondaryOutcomes': [{'measure': 'MAE-free survival rate.', 'timeFrame': '12 months', 'description': 'Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.\n\nExclusion Criteria:\n\n* Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.'}, 'identificationModule': {'nctId': 'NCT01667393', 'acronym': 'PARADIGM', 'briefTitle': 'Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System', 'orgStudyIdInfo': {'id': 'IDEV POP-01-US/OUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDEV SUPERA Stent', 'description': 'Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.', 'interventionNames': ['Device: IDEV SUPERA Stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous Transluminal Angioplasty', 'description': 'The target lesion will be treated by PTA alone.', 'interventionNames': ['Device: Percutaneous Transluminal Angioplasty']}], 'interventions': [{'name': 'IDEV SUPERA Stent', 'type': 'DEVICE', 'armGroupLabels': ['IDEV SUPERA Stent']}, {'name': 'Percutaneous Transluminal Angioplasty', 'type': 'DEVICE', 'armGroupLabels': ['Percutaneous Transluminal Angioplasty']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}