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Sponsored by: |
W.L.Gore & Associates |
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Information provided by: | W.L.Gore & Associates |
ClinicalTrials.gov Identifier: | NCT00205790 |
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
Condition | Intervention |
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Peripheral Vascular Diseases |
Device: Vascular graft |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Georgetown University Hospital | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Memorial Regional Hospital | |
Hollywood, Florida, United States, 33028 | |
St. Vincent's Hospital | |
Jacksonville, Florida, United States, 32204 | |
Sacred Heart Hospital | |
Pensacola, Florida, United States, 32504 | |
United States, Georgia | |
Medical Center of Central Georgia | |
Macon, Georgia, United States, 31201 | |
United States, Kentucky | |
Jewish Hospital | |
Louisville, Kentucky, United States, 40202 | |
United States, Maryland | |
Upper Chesapeake Medical Center | |
Baltimore, Maryland, United States, 21014 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01107 | |
Mercy Medical Center | |
Springfield, Massachusetts, United States, 01107 | |
United States, Michigan | |
Borgess Hospital | |
Kalamazoo, Michigan, United States, 49048 | |
William Beaumont Hospital | |
Bingham Farms, Michigan, United States, 48025 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 | |
United States, New Jersey | |
Morristown Memorial Hospital | |
Morristown, New Jersey, United States, 07960 | |
United States, New York | |
Maimonides Hospital | |
Brooklyn, New York, United States, 11219 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Wilkes-Barre General Hospital | |
Plains, Pennsylvania, United States, 18705 | |
United States, Tennessee | |
Baptist East Hospital | |
Memphis, Tennessee, United States, 38120 | |
United States, West Virginia | |
Charleston Area Medical Center | |
Charleston, West Virginia, United States, 25304 |
Principal Investigator: | Enrico Ascher, MD | Maimonides Hospital, Brooklyn NY |
Study ID Numbers: | PPT-01-04 |
Study First Received: | September 12, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00205790 |
Health Authority: | United States: Food and Drug Administration |
Peripheral Vascular Diseases Vascular Diseases |
Cardiovascular Diseases |