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Sponsored by: |
W.L.Gore & Associates |
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Information provided by: | W.L.Gore & Associates |
ClinicalTrials.gov Identifier: | NCT00593814 |
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
Condition | Intervention | Phase |
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Aortic Aneurysm, Abdominal |
Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Enodoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms |
Enrollment: | 139 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | WL Gore & Associates ( Erin Tims ) |
Study ID Numbers: | AAA 04-04 |
Study First Received: | December 20, 2007 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00593814 |
Health Authority: | United States: Food and Drug Administration |
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Abdominal aortic aneurysm Vascular Diseases Aortic Aneurysm |
Cardiovascular Diseases |