Study of the GORE45 Ascending Stent Graft Device for Treating New Type A Aortic Dissections in High-Risk Patients

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the GORE45 Ascending Stent Graft ASG device for treating de novo Type A aortic dissections in patients who are considered high-risk for open surgical repair. This is a prospective, multicenter, non-randomized, single-arm study focusing on patients with dissections of 30 days or less from symptom onset for the primary group, with a secondary group allowing up to 90 days. The study aims to gather important data on this devices performance in this serious condition. Participants will receive treatment with the ASG device via endovascular aortic repair targeting the ascending aorta. The study includes two arms the primary arm where the device is used alone within 30 days of symptom onset, and a secondary arm where the device may be used alone or in combination with another device for patients up to 90 days from symptom onset. Additional procedures not involving contact with the ASG device may be performed during the initial endovascular procedure as deemed necessary by the investigator. During the study, participants will undergo imaging and clinical follow-up for up to five years to monitor safety and effectiveness outcomes, including primary safety and effectiveness endpoints assessed at 30 days and secondary endpoints at one year. The study involves regular evaluations to track healing and complications, ensuring adherence to protocol requirements. Participants will be closely monitored throughout the study period to support comprehensive data collection on treatment results.

GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections