Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Safety
Study Overview
Brief Summary
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).
Detailed Description
Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rutherford clinical category 2, 3 or 4
- •ABI less than or equal to 0.90
- •Reference vessel diameter is between 2.5mm and 5.5mm
- •Target lesion has stenosis greater than or equal to 70% or is occluded
- •Target lesion is less than or equal to 10cm in length
Exclusion Criteria
- •Previously implanted stent in the ipsilateral superficial femoral or popliteal artery
- •Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)
Outcomes
Primary Outcomes
Safety
Time Frame: 30 days
Composite of new-onset major device-related adverse events.
Secondary Outcomes
No secondary outcomes reported