Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (FINEST)

Inclusion Criteria:

• Patient requires either above-knee or below-knee femoral popliteal bypass;
• Patient has Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
• Patient is at least 21 years of age;
• Patient has postoperative life expectancy of >18 months;
• Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

• Patient has a previous history of bypass in the diseased extremity (below iliacs);
• Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
• Patient has active infection in the region of graft placement;
• Patient has an acute arterial occlusion requiring an emergent intervention;
• Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
• Patient has known hypersensitivity or contraindication to aspirin;
• Patient has known coagulation disorders including hypercoagulability;
• Patient has previous instance of Heparin induced Thrombocytopenia type 2 or has known hypersensitivity to heparin;
• Patient has severe chronic renal insufficiency, is undergoing hemodialysis. or has prior renal transplant;
• Patient had a stroke or MI within 6 weeks of the procedure;
• Patient is a woman of reproductive potential.