Evaluation of FUSION™ Vascular Graft for Above Knee Targets

Inclusion Criteria: * No known malignant disease * Patient was willing and able to have follow-up visits and examinations * Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery * Patient was not participating in other clinical trials that would conflict with this protocol * Patient agreed to the study provisions and provided written informed consent Exclusion Criteria: * Urgent or emergent surgery of any kind * Documented acute or suspected systemic infection * Life expectancy of less than one year * Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke * Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris * Severe chronic renal insufficiency or undergoing hemodialysis * Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment * Medical conditions requiring oral anticoagulation * Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin * International normalized ratio (INR) \> 2.0 * Known hypersensitivity to heparin * Patient not tolerating aspirin * Previous history of bypass surgery in the target limb * Patient with category 6 ischemia (tissue los…