Trial ID or NCT#

NCT00522535

Status

NOT 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

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Jason T. Lee
Vascular surgeon
Professor of Surgery (Vascular Surgery) at the Stanford University Medical Center
Ronald L. Dalman MD
Vascular surgeon
Walter Clifford Chidester and Elsa Rooney Chidester Professor of Surgery

Contact us to find out if this trial is right for you.

CONTACT

Jason Lee
(650) 725-5227