Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
Phase 2
Completed
- Conditions
- Peripheral Arterial Disease (PAD)
- Registration Number
- NCT00196066
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
- Secondary Outcome Measures
Name Time Method Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.