Clinical Trials Directory

Prospective Aneurysm Trial: High Angle Aorfix? Bifurcated Stent Graft

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.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • device : Stent Graft
  • procedure : Open surgical repair

Phase: N/A


Ages Eligible For Study:

21 Years - N/A

Inclusion Criteria

- Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or - Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.

External Links

Explore related trials

Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee
Not Recruiting

Footer Links: