Status:
COMPLETED
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
Lead Sponsor:
Cook Group Incorporated
Conditions:
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00196066
Start Date
October 1 2002
End Date
April 1 2006
Last Update
May 10 2023
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