Clinical Trial: The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms

Brief Summary: The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.

Detailed Summary:
Sponsor: Altura Medical Inc.

Current Primary Outcome: The rate of major adverse events. [ Time Frame: 30 days ]

Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise.


Original Primary Outcome: The rate of major adverse events. [ Time Frame: 30 days ]

Adverse events defined as the composite endpoint of death, blood loss requiring intervention, repiratory failure, pulmonary embolism, myocardial infarction, renal failure, adynamic ileus, bowel ischemia and/or device migration causing vascular compromise.


Current Secondary Outcome: Feasibility of device defined by clinical and technical success [ Time Frame: 6 months, 1 year and 2 years ]

Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years.


Original Secondary Outcome:

Information By: Altura Medical Inc.

Dates:
Date Received: May 2, 2011
Date Started: April 2011
Date Completion: May 2019
Last Updated: January 13, 2015
Last Verified: January 2015