PROMISE International

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 (GF…