NCT04765592

Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)

Detailed description

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

Conditions

• Aortic Arch Aneurysm

Interventions

Type	Name	Description
DEVICE	WeFlow-Arch Modeler Embedded Branch Stent Graft System	The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.

Timeline

• Start date: 2021-06-07
• Primary completion: 2025-02-05
• Completion: 2029-02-05
• First posted: 2021-02-21
• Last updated: 2024-04-30

Locations

23 sites across 1 country: China