NCT02323581 Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
| NCT ID | NCT02323581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Darren Schneider, M.D. |
| Condition | Aortic Aneurysm, Thoracoabdominal |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2013-11 |
| Primary Completion | 2028-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
Eligibility Criteria
TAAA STUDY ARM Inclusion Criteria: 1. Presence of TAAA in: 1. Men with TAAA greater than or equal to 6 cm in diameter 2. Women with TAAA greater than or equal to 5 cm in diameter 3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year 4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or 5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter 2. Life expectancy more than 2 years 3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol 4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device": 1. Proximal aortic landing zone: * ≥ 20mm long * ≤ 40mm and ≥ 20mm diameter in parallel aorta * free from circumferential thrombus * ≤ 60 degrees angulation 2. Mesenteric/renal aortic diameter ≥ 20mm 3. Mesenteric arteries: * ≥ 10mm long segment of healthy artery for branch attachment * Diam