Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries (MELODIE)

Inclusion Criteria: chronic symptomatic atherosclerotic disease in the iliac arteries (Fontaine Class IIa, IIb, and III) atherosclerotic de novo or restenotic lesions in the common and/or external iliac artery. baseline diameter stenosis of > or = 50% reference vessel diameter > or = 5mm and < or = 10mm at least one sufficient ipsilateral infrapopliteal run-off length of diseased segment(s) < or = 10cm and can be treated with maximally two overlapping Express Vascular LD Stents. multiple target lesions of the iliac arteries in the same patient can be included provided if each target lesion is compliant with the antiographic inclusion criteria and non-compliant with any of the antiographic exclusion criteria, target lesions are not located in the same target axis, and all target lesions can be treated during the same procedure. Exclusion Criteria: chronic symptomatic atherosclerotic disease classified as fontaine Class I or IV acute leg ischemia pregnants patients patients with uncorrected bleeding disorders (platelets < 150 000/mm3 or > 450 000 mm3, or patient who cannot receive anticoagulation or antiplatelet aggregation therapy patient with known allergy to stainless steel known anaphylactoid or other non-anaphylactic reactions to contrast agents that cannot be adequately premedicated prior to the index procedure life-expectancy of less than 24 months due to other medical co-morbid condition that could limit patient's ability to participate in the study, the patient's compliance with the follow-up requirements or impact the scientific integrity of the study patient currently participating in another study that has not yet completed the primary endpoint or that clinically interferes with the endpoint of this study patients who have already participated in this study patients with prior or planned bypass surgery of the target vessel patient with prior stent placement in the target vessel patient with any previous coronary intervention within the last 30 days before enrollment into this study or patients with planned coronary intervention within 30 days after enrollment into this study. patients in whom the origin of the profunda femoris and superficial femoral artery is occluded in the limb supplied by the iliac artery to be treated without planned surgical repair patients with heavily calcified and excessive tortuous lesions at the target site as determined by angiography patients with target lesion which is within or adjacent to the proximal or distal segment of an aneurysm patients with persistent, acute intraluminal thrombus of the proposed target lesion site post-thrombolytic therapy patients with perforated vessels as evidenced by extravasation of contrast media patients with multiple lesions in the same target vessels.