GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)

The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.

Inclusion Criteria:>

• lifestyle limiting claudication, rest pain or minor tissue loss>
• ABI (ankle-brachial index) < 0.9 or TBI (toe-brachial index) < 0.5 if ABI is >0.9
• Stenosis (>50%) or occlusion of native SFA (superficial femoral artery) >5cm
• Orifice and 1 cm of SFA are patent
• Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
• At least 1 patent run off vessel
• Guidewire and deliver system successfully traversed the lesion

Exclusion Criteria:>

• Untreated flow-limiting aortoiliac occlusive disease
• Any previous stenting or surgery in the target vessel
• Femoral or popliteal aneurysm of target vessel
• No patent tibial arteries
• Prior ipsilateral femoral artery bypass
• Major distal amputation (above the transmetatarsal) in either limb
• Patients with known sensitivity to Heparin