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

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.