NCT07170332

ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection

Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (estimated)
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system

Detailed description

The study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 127 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch dissections, residual dissection following ascending aorta surgical operation.

Conditions

• Dissection of Aortic Arch

Interventions

Type	Name	Description
DEVICE	ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection	The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-09-30
• Completion: 2032-09-30
• First posted: 2025-09-12
• Last updated: 2025-09-15