Tack Optimized Balloon Angioplasty Post-Market Study

Stopped early

Conditions studied: PAD - Peripheral Arterial Disease, PAD, Dissection, Arterial Dissection, Peripheral Arterial Disease, Peripheral Vascular Diseases

In brief

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.

Key facts

Study ID

NCT05361967

Run by

Spectranetics Corporation

People needed

6

Starts

2023-03-30

Expected to finish

2024-06-01

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Heart and Vein Center - Thornton — Thornton, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Palm Vascular Center Research — Fort Lauderdale, Florida, United States
• Munster Medical Research Foundation — Munster, Indiana, United States
• Advanced Heart and Vascular Institute of Hunterdon — Flemington, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Ascension St. John Heart and Vascular Center — Bartlesville, Oklahoma, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• North Dallas Research Associates — McKinney, Texas, United States

Full record on ClinicalTrials.gov

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