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The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treovance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System | Device | Stent-graft implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| major morbidity and mortality | 1, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months | implant, 1, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States | ||
| Spectrum Health System |
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AAA device
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| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| Carolinas Sanger Heart and Vascular | Charlotte | North Carolina | 28203 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sentara Heart Hospital | Norfolk | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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