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The purpose of this study is to evaluate the clinical performance of the Zenith Alphaâ„¢ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith Alphaâ„¢ Abdominal Endovascular Graft | Device | Zenith Alphaâ„¢ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Forbes, MD | Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Hospital and Health Science Center | Vancouver | British Columbia | V6T 2B5 | Canada | ||
| Nova Soctia Health Authority |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39892792 | Derived | Lindsay TF, Harlock J, Herman C, Chen J, Power A, Saunders AT. A Canadian postmarket study of the Zenith Alpha Abdominal Endovascular Graft. J Vasc Surg. 2025 May;81(5):1058-1066.e1. doi: 10.1016/j.jvs.2025.01.196. Epub 2025 Jan 30. |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001014 | Aortic Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D017543 | Iliac Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| Halifax |
| Nova Scotia |
| B3H3A7 |
| Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada |
| London Health Sciences Center | London | Ontario | N6A 4G5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 1X6 | Canada |