Clinical Trial: Endovascular Exclusion of Ascending and Thoracic Aortic Pathology

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

Official Title: Endovascular Exclusion of Ascending and Thoracic Aortic Pathology

Brief Summary: The purpose of this study is to assess the role of ascending and/or aortic arch aneurysm/dissections treatment using a novel endovascular prosthesis in high risk surgical patients.

Detailed Summary: This study is a prospective, non-randomized evaluation of ascending and thoracic pathology endovascular repair in the high-risk patient. The purpose of this study is to assess the role of the thoracic aortic pathology treatment using endovascular prosthesis in high-risk patients. The study objectives include (1) to assess the safety and efficacy of endovascular prosthesis as a means of preventing aneurysm growth and rupture in high risk patients, (2) to measure the physiologic effects and outcomes of endovascular aneurysm repair, (3) to establish selection criteria, improve device design, operative technique, and follow-up procedures for patients undergoing aneurysm repair. There will be up to 15 patients in the ascending aortic lesion arm and 20 patients in Arch Branch arm; all at one site (The Cleveland Clinic). Baseline procedures may include an angiogram, intravascular ultrasound, CT scan, chest x-ray, physical exam, blood work, and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia. Follow-up evaluations may include physical exam, blood work, CT scan or MRI, chest x-ray, cardiac echo and 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: May 2001
Date Completion: December 2020
Last Updated: April 12, 2017
Last Verified: April 2017