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Sponsored by: |
Cook |
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Information provided by: | Cook |
ClinicalTrials.gov Identifier: | NCT00196066 |
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.
Condition | Intervention | Phase |
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Peripheral Arterial Disease (PAD) |
Device: Peripheral Vessel Stenting |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 150 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 02-513 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00196066 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Peripheral Vascular Diseases Vascular Diseases |
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |