Clinical Trial: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Brief Summary: The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Detailed Summary: This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.
Sponsor: Matthew Eagleton

Current Primary Outcome: Freedom from Aneurysm Rupture [ Time Frame: 2 years ]

Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan


Original Primary Outcome: Saftey [ Time Frame: Undecided ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Cleveland Clinic

Dates:
Date Received: December 20, 2007
Date Started: September 1998
Date Completion: December 2020
Last Updated: April 12, 2017
Last Verified: April 2017