NCT00442065

ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels

A Study to Assess the Acute Technical Success of Aorfix™ Stent Grafts in the Treatment of Abdominal Aortic and Aorto-Iliac Aneurysm Where a Significant Degree of Vessel Angulation Exists at the Neck of the Aneurysm

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lombard Medical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.

Detailed description

The Aorfix™ Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is \<65o. The objective of this study is to evaluate the safety and performance of the bifurcated Aorfix™ Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated \> 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication. The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Aorfix™ Stent Grafts (AAA endovascular procedure)	Endovascular treatment of AAA using the Aorfix™ Stent Graft and Delivery System

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-03-01
• Last updated: 2012-10-17

Locations

6 sites across 5 countries: Czechia, Germany, Poland, Spain, United Kingdom