Clinical Trial: Zenith Alpha™ Abdominal Endovascular Graft

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft

Brief Summary: The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Detailed Summary:
Sponsor: Cook

Current Primary Outcome: Device Success [ Time Frame: 2 years ]

Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cook

Dates:
Date Received: February 20, 2017
Date Started: May 2017
Date Completion: April 2020
Last Updated: May 19, 2017
Last Verified: February 2017