Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries

A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.

Inclusion Criteria:

• Patient presenting with rest pain or minor tissue loss (Rutherford Clinical Category 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 a Self-Expanding Paclitaxel-Eluting stent
• 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
• Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography
• Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm
• Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot.
• Guidewire successfully traversed lesion
• Length of target lesion is <50mm

Exclusion Criteria:

• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Has had a previous peripheral bypass affecting the target limb
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used
• Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated
• Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion
• Life expectancy of less than 12 months
• Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints
• Patient has other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention
• Has end-stage renal disease defined as undergoing hemodialysis for kidney failure
• 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
• Treatment of ipsilateral non-study inflow lesions with other materials than regular guidewires, regular PTA balloons, bare metal stents and/or paclitaxel-coated stents
• Additional treatments of the study lesion requiring materials/procedures other than standard guidewires, regular PTA balloons and/or a Self-Expanding Paclitaxel-Eluting stent (e.g. thrombectomy, re-entry catheters, CTO-wires, cutting balloon, cryoballoon, etc)