Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery

Clinical Inclusion Criteria:

• Subject must be at least 18 and 2.0 mg/dl.
• Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).
• Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
• Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.
• Subject has unstable angina defined as rest angina with ECG changes.
• Subject has a groin infection, or an acute systemic infection that is currently under treatment.
• Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
• Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.
• Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).
• Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.
• Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
• If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
• Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).
• Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
• Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
• If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
• Requirement of general anesthesia or spinal block for the procedure.
• Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
• Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
• Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
• Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

• Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
• Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
• Target lesion is within or adjacent to an aneurysm.
• Lesion is located within or beyond a vessel that contains a bypass graft.
• Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
• Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
• Lesion extends beyond the inguinal ligament.
• Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
• Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
• On the tre