PROMISE International

Exclusion Criteria

• •Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
• •Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
• •Life expectancy less than 12 months
• •Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
• •Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
• •Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
• •Patient unable to give consent
• •Pregnant or breastfeeding women
• •Documented myocardial infarction or stroke within previous 90 days
• •Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
• •Patients with vasculitis and/or untreated popliteal aneurysms
• •Patients with acute limb ischemia
• •Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
• •Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
• •Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
• •Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
• •Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of \< 40%, NYHA Classification III-IV)