Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.

Inclusion Criteria:

• Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
• Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
• Patient has given informed consent.

Exclusion Criteria:

• Patient is less than 50 years of age
• Patient is participating in another investigational drug or device study.
• Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
• Patient is pregnant or breast-feeding.