NCT05800743

Evaluation of the GORE® Ascending Stent Graft

Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.

Conditions

• Aortic Aneurysm, Thoracic
• Pseudoaneurysm
• Aortic Dissection
• Aorta; Lesion

Interventions

Type	Name	Description
DEVICE	GORE® Ascending Stent Graft (ASG device)	Endovascular aortic repair of the ascending aorta
DEVICE	GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)	Endovascular aortic repair of the ascending aorta/aortic arch
PROCEDURE	Surgery	Open surgical repair of the ascending aorta and/or the aortic arch

Timeline

• Start date: 2023-11-28
• Primary completion: 2029-10-01
• Completion: 2034-01-01
• First posted: 2023-04-06
• Last updated: 2025-09-10

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated device study