Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Trial ID or NCT#

NCT00522535

Status

not recruiting iconNOT RECRUITING

Purpose

Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months. Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group. Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.

Official Title

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

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Contact

Jason Lee
6507255227