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Sponsored by: |
Arizona Heart Institute |
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Information provided by: | Arizona Heart Institute |
ClinicalTrials.gov Identifier: | NCT00546312 |
This study is to evaluate safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.
Condition | Intervention |
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Descending Thoracic Aortic Disease |
Device: Thoracic EXCLUDER Endoprosthesis |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases |
Estimated Enrollment: | 332 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (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:
Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm.
Exclusion Criteria:
Contact: Christopher DiMatteo, BS | 602-266-2200 ext 3624 | cdimatteo@azheart.com |
Contact: James Williams, BS | 602-266-2200 ext 3605 | jwilliams@azheart.com |
United States, Arizona | |
Arizona Heart Institute | Recruiting |
Phoenix, Arizona, United States, 85006 | |
Principal Investigator: Edward B Diethrich, M.D. | |
Sub-Investigator: Julio Rodriguez-Lopez, M.D. | |
Sub-Investigator: Venkatesh Ramaiah, M.D. | |
Sub-Investigator: Grayson Wheatley, M.D. |
Principal Investigator: | Edward B Diethrich, M.D. | Arizona Heart Institute |
Responsible Party: | Arizona Heart Institute ( Edward B. Diethrich, MD ) |
Study ID Numbers: | G990299 |
Study First Received: | October 16, 2007 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00546312 History of Changes |
Health Authority: | United States: Institutional Review Board |
Aortic Diseases Vascular Diseases |
Aortic Diseases Vascular Diseases Cardiovascular Diseases |