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Full Title Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Protocol Number PYTHAGORAS
clinicaltrials.gov https://clinicaltrials.gov/show/NCT00522535
Principal Investigator(s) Girma Tefera, MD
Division Vascular Surgery
Status Active, not recruiting
Description

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.

Other Clinical Trials in the Department of Surgery
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