NCT06827990

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Detailed 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.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	GORE® Ascending Stent Graft (ASG device)	Endovascular aortic repair of the ascending aorta

Timeline

• Start date: 2025-09-22
• Primary completion: 2030-09-01
• Completion: 2031-09-01
• First posted: 2025-02-14
• Last updated: 2026-04-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study