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Recruiting NCT02089607

CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

Trial Parameters

Condition Complex Abdominal Aortic Aneurysm
Sponsor Baylor College of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 760
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2014-03
Completion 2027-03
Interventions
CAAA and TAAA ArmAortic Arch Aneurysm Arm

Brief 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.

Eligibility Criteria

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 consent by the patient or a legally authorized representative * Pregnant or breastfeeding * Life expectancy \< 2 years * Prior open surgical or interventional procedure within 30 days of the anticipated dat

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