CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
| Condition(s) | Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Aortic Arch Dissection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm. |
| Who can participate | General Inclusion Criteria: * Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter. * Aneurysm with a history of growth ≥ 0.5 cm per year. * Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation. * Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria. * Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation. General Exclusion Criteria: * Less than 18 years of age * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consen |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Baylor College of Medicine |
| Locations | Rochester, Minnesota, United States; Houston, Texas, United States; Houston, Texas, United States |
| Start date | 2014-03 |
| NCT ID | NCT02089607 |
| Official listing | https://clinicaltrials.gov/study/NCT02089607 |