Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- Philips Clinical & Medical Affairs Global
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 5 years ago
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).
Investigators
Eligibility Criteria
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.