GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Trial Parameters
Brief Summary
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
Eligibility Criteria
Inclusion Criteria - Primary Arm: The subject is/has: 1. De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device. 2. Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator. 3. Anatomic compatibility of the ascending aorta required for implanting the ASG device: a) Proximal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium. ii. Total aortic diameter between 27mm - 48mm iii. Landing zone cannot be heavily calcified or thrombosed. b) Distal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium. c) Adequate aortic length 4. The Aortic Treatment Team (as defined by the