Tack Optimized Balloon Angioplasty (TOBA) Study

Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler

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).

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).

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)