Evaluation of the GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
W.L.Gore & Associates
Summary
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
Description
This pivotal investigation is a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the ASG device for the treatment of de novo Type A aortic dissections in patients considered to be high-risk for open surgical repair.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Prim…
Interventions
- DeviceGORE® Ascending Stent Graft (ASG device)
Endovascular aortic repair of the ascending aorta
Locations (16)
- University of Alabama at BirminghamBirmingham, Alabama
- University of Southern CaliforniaLos Angeles, California
- University of FloridaGainesville, Florida
- Emory University School of MedicineAtlanta, Georgia
- Northwestern MedicineChicago, Illinois
- Indiana UniversityIndianapolis, Indiana