4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

Inclusion Criteria: * De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment * Patient presenting with a score from 2 to 4 according to the Rutherford classification * Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times * Patient is \>18 years old * Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study * Prior to enrollment, the target lesion was crossed with standard guidewire manipulation * Patient is eligible for treatment with 4F compatible devices Angiographic Inclusion Criteria: * The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis. * The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion * Length of the target lesion is =20 cm by visual estimation and can be covered with one stent * Target vessel diameter visually estimated is =4 mm 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 bypass surgery in the same limb * Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics * Patients who exhibit persistent acute intraluminal thrombus at the target 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 * Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * Life expectancy of less than 12 months * Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30% * Use of thrombectomy, atherectomy or laser devices during procedure * Any planned surgical intervention/procedure 30 days after 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 reached the primary endpoint