Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries

Inclusion Criteria: * Patient presenting with rest pain or minor tissue loss (Rutherford Clinical Category 4 or 5) * Patient is willing to comply with specified follow-up evaluations at the specified times * Patient is \>18 years old * Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * Patient has a projected life-expectancy of at least 12 months * Patient is eligible for treatment with a Self-Expanding Paclitaxel-Eluting stent * Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure * Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography * Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm * Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot. * Guidewire successfully traversed lesion * Length of target lesion is \<50mm Exclusion Criteria: * Untreated flow-limiting inflow lesions * Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment * Has had a previous peripheral bypass affecting the target limb * Major distal amputation (above the transmetatarsal) in the study limb or non-study limb * Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) * Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used * Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated * Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion * Life expectancy of less than 12 months * Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints * Patient has other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention * Has end-stage renal disease defined as undergoing hemodialysis for kidney failure * Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure * Patient with known hypersensitivity to heparin, including those patients who have had a previo…