NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

Inclusion Criteria: * Patient presenting with rest pain or minor tissue loss (Rutherford class 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 the NanoCrossTM .014 balloon catheter (Covidien) * 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 * De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries,suitable for endovascular therapy * Total target lesion length minimally 100mm * Target vessel diameter visually estimated to be \>1.5mm and \<4.0mm * Guidewire and delivery system successfully traversed lesion * At least one non-occluded crural artery with angiographically documented run- off to the foot. Exclusion Criteria: * Patient refusing treatment * The reference segment diameter is not suitable for the available balloon design * Untreated flow-limiting inflow lesions * Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment * Any previous surgery in the target vessel (including prior ipsilateral crural bypass) * Aneurysm in the target vessel * Target lesion has severe calcification as determined by physician's discretion * Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) * Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy * Major distal amputation (above the transmetatarsal) in the study limb or non- study limb * Septicemia or bacteremia * Any previously known coagulation disorder, including hypercoagulability * Contraindication to anticoagulation or antiplatelet therapy * 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 previous incidence of heparin-induced thrombocytopenia (HIT) type II * Currently participating in another clinical research trial * Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment * Target lesion access not performed by transfemoral approach.