a Physician-inititated Trial Investigating the iVolution Nitinol Stent

Inclusion criteria

• De novo 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 and able to comply with specified follow-up evaluations at the predefined time intervals
• 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 One target lesion is located within the native SFA: distal point 3 cm above knee joint
• The target lesion has angiographic evidence of stenosis or occlusion
• Length of the target lesion is ≤ 15 cm by visual estimation
• Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
• There is angiographic evidence of at least one vessel-runoff to the foot

Exclusion criteria

• Presence of a 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 or other study device components
• 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 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