GORE-TEX PROPATEN Vascular Graft Study

Exclusion Criteria

• •Patient had a previous bypass in the diseased extremity (below iliacs);
• •Patient has known coagulation disorders including hypercoagulability;
• •Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
• •Patient has an acute embolic arterial occlusion;
• •Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
• •Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
• •Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
• •Patient has active infection in the region of graft placement; or
• •Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.