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This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relay Thoracic Stent-Graft | Device | Device implant |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Hospital | Phoenix | Arizona | 85006 | United States | ||
| Washington Hospital Center |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| Indiana Heart Hospital | Indianapolis | Indiana | 46250 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Sentara Heart Hospital | Norfolk | Virginia | 23510 | United States |
| University Washington | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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