IRB Study Number 23-806
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This research study is looking at treating ascending and in the arch, aortic diseases with a new investigational medical device called the GORE® Ascending Stent Graft (ASG device) and new device delivery system called the GORE@Many times this type of aortic disease is treated with open-chest surgery to repair or replace the diseased part of the aorta, but in this research study, participants may be treated endovascularly and enrolled into three arms. Including those who are treated with the study ASC device, or treated with the study ASC device and additional, already FDA approved GORE TAG device(s) and others will be followed if they have undergone an open procedure surgery.
Inclusion Criteria
Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device, Anatomic compatibility with ASG device based on Gore Imaging Sciences, Considered high-risk for open surgical repair
Exclusion Criteria
De novo Type A dissection, Requires immediate treatment, Dissected great vessels requiring treatment
