Bolton RelayPro

Protocol: 
AAAQ9313

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

  • This trial is a prospective, multicenter, non-blinded, non-randomized study of the Relay PRO Thoracic Stent-Graft in subjects with Thoracic Aortic Aneurysms (TAAs) and Penetrating Atherosclerotic Ulcers (PAUs)
  • The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and PAUs within the descending thoracic aorta.
  • The primary safety objective is a composite of the number of Major Adverse Events (MAEs) occurring through 30 days post-procedure compared to the rate in subjects treated with the Relay Thoracic Stent-Graft in the U.S. Pivotal Trial (P110038).
  • 12 month trial, with each patient having minimum of 30 day follow-up

Are you Eligible? (Inclusion Criteria)

       ●    18 years or older
       ●     Subject has any of the following conditions in his/her descending thoracic aorta:
a)     Aneurysm ≥5.0cmin diameter;
b)     Aneurysm ≥4.0cmin diameter with an increase of  ≥0.5 cm within the last 6 months or  ≥1.0 cm over the last 12 months;
c)     Aneurysm with maximumdiameter exceedingtwotimes the diameterofthe non-aneurysmal, adjacentaorta;
d)     saccular aneurysm;
e)     Penetrating Atherosclerotic Ulcers.

Specialty Area(s)

Trial Location

Claudia Musat, MD
Columbia University Medical Center
161 Fort Washington Avenue
Herbert Irving Pavilion 5-548
New York, NY 10032
United States