NCT00522535

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Lombard Medical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
PROCEDURE	Open surgical repair	Open surgical repair of abdominal aortic aneurysm
DEVICE	Stent Graft	Endovascular repair of abdominal aortic aneurysm (EVAR)

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-09-01
• Completion: 2020-07-01
• First posted: 2007-08-29
• Last updated: 2021-10-26

Locations

38 sites across 1 country: United States