Tack Optimized Balloon Angioplasty Post-Market Study
Reason given: Terminated due to slow enrollment
Key facts
- Where
- Bartlesville, Dallas, Flemington, Fort Lauderdale, Hackensack, Hartford, McKinney, Munster, Providence, and Thornton, United StatesSee the 10 sites
Where in United States
- Ascension St. John Heart and Vascular CenterBartlesville, United StatesNo longer taking part
- University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part
- Advanced Heart and Vascular Institute of HunterdonFlemington, United StatesNo longer taking part
- Palm Vascular Center ResearchFort Lauderdale, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Hartford HospitalHartford, United StatesNo longer taking part
- North Dallas Research AssociatesMcKinney, United StatesNo longer taking part
- Munster Medical Research FoundationMunster, United StatesNo longer taking part
- The Miriam HospitalProvidence, United StatesNo longer taking part
- Advanced Heart and Vein Center - ThorntonThornton, United StatesNo longer taking part
Trial details
- Who runs it
- Spectranetics Corporation
- Trial code
- NCT05361967
- Record updated
- 9 August 2024
- Original description
The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.Read full original descriptionShow less
The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.
Inclusion: General Inclusion Criteria; Age ≥ 18 years; Willingness to comply with study follow-up evaluations at the predefined time intervals; Signs the written informed consent; Meets Rutherford classification criteria:; ATK subjects can be RCC 3, 4 or 5; BTK subjects must be RCC 4 or 5; Angiographic Inclusion Criteria; A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate); ATK Lesions:; must be in the superficial femoral and/or proximal popliteal (P1) arteries and; have a reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm; BTK Lesions:; must be in the mid/distal popliteal (P2/P3), peroneal and/or tibial arteries and; have a reference vessel diameter range of 1.5-4.5mm Note: The mid popliteal artery begins at the superior aspect of the patella; Post-IVUS Inclusion Criteria; Presence of an arterial dissection requiring repair per investigator judgement; ATK reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm; BTK reference vessel diameter range of 1.5-4.5mm.
Exclusion: Contraindication to anticoagulation and/or antiplatelet therapy; Known allergy to contrast media that cannot be adequately pre-medicated prior to index procedure; Previous or planned surgical or interventional procedure within 3 days before or 30 days after the index procedure; Note: this excludes successful inflow artery treatment within the same hospitalization or a documented pre-planned minor amputation; Known COVID positive test within 14 days and active symptoms; Known renal disease that precludes contrast administration; Known allergy to nitinol (nickel and/or titanium); Subject has any condition that in the opinion of the investigator precludes the subject from participation; Angiographic Exclusion Criteria; Aneurysm, acute or sub-acute thrombosis in target lesion; General Exclusion Criteria; Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study; Anticipated life expectancy < 12 months; Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA); Residual diameter stenosis ≥30% (visual estimate) after PTA; Acute vessel occlusion after PTA not attributed to dissection.