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 clinicaltrials.gov to see if other locations are recruiting.
- device : Stent Graft
- procedure : Open surgical repair
Ages Eligible For Study:
- 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.