Physician Initiated Trial Investigating the Efficacy of the Implant of EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions

Date de début de l'étude : 1 mars 2008

Inclusion Criteria: GENERAL * De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for stenting * Patient presenting a score from 2 to 5 following Rutherford classification * Patient is willing to comply with specified follow-up evaluations at the specified times * Patient is \>18 years old * Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * Prior to enrollment, the guidewire has crossed target lesion * Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent ANGIOGRAPHIC * The target lesion is located within the native femoropopliteal artery until maximally 3 cm proximally of the knee joint. * The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation * The target lesion, visually estimated, has a minimal length of 15 cm and can be categorized as either a type C or D lesions according the TASC II guidelines * Target vessel diameter visually estimated is \>4mm and \<6.5 mm * There is angiographic evidence of at least one-vessel-runoff to the foot Exclusion Criteria: * Presence of another stent in the target vessel that was placed during a previous procedure * Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis * Previous by-pass surgery in the same limb * Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site * Perforation at the angioplasty site evidenced by extravasation of contrast medium * Patients with known hypersensitivity to nickel-titanium * Patients with uncorrected bleeding disorders * Aneurysm located at the level of the SFA * Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * Life expectancy of less than twelve months * Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure * Use of thrombectomy, artherectomy or laser devices during procedure * Any planned surgical intervention/procedure within 30 days of the study procedure * Any patient considered to be hemodynamically unstable at onset of procedure * Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.