Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease

A Prospective, Randomized, Multicenter Comparison of Balloon Angioplasty and the Cypher Selecttm + Coronary and Infrapopliteal Stent in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease

The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.

This is a multicenter, prospective, randomized study to be conducted in 18 centers in Europe. A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4, or 5).

All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months.

Inclusion Criteria:

• Subject must be >= 18 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 or restenotic (after PTA only) lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery;
• A maximum of 2 vessels in 1 limb may be treated in the study, each vessel for only 1 target lesion, resulting in at single risk target lesion(s); In case 1 target lesion is located in the Tibioperoneal trunk, the 2nd target lesion (if applicable) can only be located in the anterior tibial artery; Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician's discretion by means of balloon dilation (± bail-out stenting);
• The sum of the total length of both target lesions can be maximum 120 mm;
• In total a maximum of 4 stents may be implanted to fully cover the maximum of 2 target lesions per subject;
• Target vessel is >= 2.5 and <= 3.5 mm in diameter (visual estimate);
• Target lesion stenosis is >70% diameter stenosis (visual estimate);
• Guidewire must be across the first (if applicable) target lesion and located intraluminally within the distal vessel before study randomization;
• 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 that might require revascularization, or impede runoff;
• Angiographic evidence of thrombus within target vessel;
• Thrombolysis within 72 hours prior to the index procedure;
• Lesions not suitable for stenting;
• Lesions (defined as stenosis > 75%) in the common or external iliac, common or superficial femoral and popliteal artery. However, intervention in TASC A and B lesions (max. 15cm) to restore adequate blood flow, in the same index procedure is allowed. This intervention must be prior to the treatment of the study lesion(s) and successful;
• Lesions located at the bifurcation requiring treatment of both branches (1 in main branch and 1 in side branch);
• Required stent placement across or within 1 cm of the knee joint; in an artery subject to external compression, or in an artery directly subject to movement of the ankle or knee joint;
• Prior stent(s) within the target vessel(s);
• Aneurysm in the SFA or popliteal artery;
• Requiring popliteal arterial access;
• Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
• Recent MI or stroke < 30 days prior to the index procedure;
• Coronary intervention < 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;
• Impaired renal function (creatinine > 2.5 mg/dl);
• Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (PlavixÒ) and ticlopidine (Ticlidâ), heparin, stainless steel or contrast agent;
• The subject is currently taking Coumarin / Warfarin which, in the opinion of the investigator, interferes with the subject's participation in the study;
• 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.