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:
- Aneurysm ≥5.0cmin diameter;
- 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;
- Aneurysm with maximumdiameter exceedingtwotimes the diameterofthe non-aneurysmal, adjacentaorta;
- saccular aneurysm;
- Penetrating Atherosclerotic Ulcers.
Claudia Musat MD
Columbia University Medical Center
161 Fort Washington Avenue
Herbert Irving Pavilion 5-548
New York, NY 10032