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Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft — PYTHAGORAS  

Abdominal Aortic Aneurysms Clinical Trial

Official title:
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00522535
Study type Interventional
Source Lombard Medical
Contact
Status Completed
Phase N/A
Start date April 2006
Completion date July 2020
View Details
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