Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions

Inclusion Criteria: * Subject must be between 50 and 85 years old * Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation * Clinical diagnosis of symptomatic critical limb ischemia as defined by Rutherford 3, 4, or 5 * Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm; * One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement * The total length of target lesion(s) can be maximum 250 mm * In total a maximum of 4 drug-coated balloons may be used to fully cover the target lesion * Target vessel is 2.0 and 3.5 mm in diameter (visual estimate) * Target lesion stenosis is \>70% diameter stenosis (visual estimate) * Guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomization * Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures. Exclusion Criteria: * Significant (\>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff; * Angiographic evidence of thrombus within target vessel * Thrombolysis within 72 hours prior to the index procedure * In-Stent restenosis or restenosis of a native artery * Aneurysm in the femoral artery or popliteal artery * Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * Recent myocardial infarction or stroke \< 30 days prior to the index procedure * Life expectancy less than 12 months * Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb * Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent * Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study * The subject is 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 study.