Tack Optimized Balloon Angioplasty Post-Market Study
(TOBA PMS Trial)
Recruiting at11 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Spectranetics Corporation
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria
Age ≥ 18 years
Willingness to comply with study follow-up evaluations at the predefined time intervals
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Treatment Details
Interventions
- The Tack Endovascular System (Vascular Repair Device)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: BTK: Below-The-KneeExperimental Treatment1 Intervention
Subjects with CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. BTK subjects will have baseline lesions in the mid/distal popliteal, peroneal and/or tibial arteries.
Group II: ATK: Above-The-KneeExperimental Treatment1 Intervention
Subjects with claudication (Rutherford 3) or CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. ATK subjects will have baseline lesions in the superficial femoral and/or proximal popliteal arteries.
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Who Is Running the Clinical Trial?
Spectranetics Corporation
Lead Sponsor
Trials
26
Recruited
4,300+