Status:
TERMINATED
Tack Optimized Balloon Angioplasty Post-Market Study
Lead Sponsor:
Spectranetics Corporation
Conditions:
PAD - Peripheral Arterial Disease
PAD
Eligibility:
All Genders
18+ years
Brief Summary
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 th...
Detailed Description
The purpose of this post-market study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions...
Eligibility Criteria
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
- General Exclusion Criteria
- Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study
- Anticipated life expectancy \< 12 months
- Known COVID positive test within 14 days and active symptoms
- Known renal disease that precludes contrast administration
- Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA)
- Contraindication to anticoagulation and/or antiplatelet therapy
- Known allergy to nitinol (nickel and/or titanium)
- 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.
- Subject has any condition that in the opinion of the investigator precludes the subject from participation
- Angiographic Exclusion Criteria
- Residual diameter stenosis ≥30% (visual estimate) after PTA
- Aneurysm, acute or sub-acute thrombosis in target lesion
- Acute vessel occlusion after PTA not attributed to dissection
Key Trial Info
Start Date :
March 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05361967
Start Date
March 30 2023
End Date
June 1 2024
Last Update
August 9 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Heart and Vein Center - Thornton
Thornton, Colorado, United States, 80023
2
Hartford Hospital
Hartford, Connecticut, United States, 06106
3
Palm Vascular Center Research
Fort Lauderdale, Florida, United States, 33312
4
Munster Medical Research Foundation
Munster, Indiana, United States, 46321