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

This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen (Germany). A total of 80 subjects will be entered into the study and will be randomized on a 1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion prior and after intervention will be performed in 15 patients of each group during index procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.

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.