Vein bypass offers hope for leg amputation patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject must be \> 21 and \< 95 years of age * Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6 * Assessment that no conventional surgical or endovascular treatment is possible * Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed * Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits 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)