Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD

Exclusion Criteria

• •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• •Acute injury or active infection (including positive cultures of pathogenic bacteria) in the limb receiving the graft
• •Stroke within six (6) months prior to study entry (Day 1)
• •Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
• •Women of child bearing potential
• •Active diagnosis of cancer within the previous year
• •Immunodeficiency including AIDS / HIV
• •Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
• •Bleeding diathesis
• •Ongoing treatment with vitamin K antagonists or direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban)
• •Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative limb
• •Previous angioplasty with stenting in the operative limb unless the graft anastomoses can be made at least 1cm distant from the site of the stent
• •Stenosis of \>50% of the external iliac artery unless it is planned to treat this stenosis with angioplasty with or without stenting prior to, or at the time of, graft implantation
• •Distal graft anastomosis likely to be below the knee
• •Active autoimmune disease - symptomatic or requiring ongoing drug therapy
• •Active local or systemic infection (WBC \> 15,000/mm3)
• •Known serious allergy to aspirin or penicillin
• •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
• •Previous enrollment in this study
• •Employees of the sponsor or patients who are employees or relatives of the investigator