Tack Optimized Balloon Angioplasty (TOBA) Study
- Conditions
- Peripheral Vascular Disease
- Interventions
- Device: Tack-It Endovascular Stapler
- Registration Number
- NCT01663818
- Lead Sponsor
- Philips Clinical & Medical Affairs Global
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Tack-It Endovascular Stapler Treatment with Tack-IT Endovascular Staple
- Primary Outcome Measures
Name Time Method Safety 30 days Composite of new-onset major device-related adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Patrick Peeters, MD
🇧🇪Bonheiden, Belgium