Clinical Trial: 34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
Brief Summary: Study of anatomical fixation with a 34mm proximal extension
Detailed Summary: The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
Sponsor: Endologix
Current Primary Outcome: Proximal Type I endoleak [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak. [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Endologix
Dates:
Date Received: May 2, 2008
Date Started: September 2005
Date Completion: September 2012
Last Updated: September 12, 2011
Last Verified: September 2011