single arm study with a nitinol self-expanding paclitaxel-eluting stent to treat btk arteries

Conditions: Peripheral Arterial Disease

Summary: 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.


Eligibility criteria:
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)

Keywords: critical limb ischemia rest pain minor tissue loss below the knee