IRB Study Number 16-1371
Status Recruiting
Phase Phase 2
Locations Cleveland Clinic Canada Midtown, Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This research study will look at treating certain aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). You may be eligible if you have one of the following: A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. OR A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. OR Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. OR A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture
Inclusion Criteria
Presence of thoracic aortic pathology deemed to warrant surgical repair;
Age ≥18 years at time of informed consent signature;
Subject is capable of complying with Protocol requirements, including follow-up
Exclusion Criteria
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair;
Previous endovascular repair of the ascending aorta;
Surgery within 30 days prior to enrollment with the exception of: Surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access-Surgery to treat any other presenting injuries in Traumatic Transection Subjects only.
