NCT05754541

Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)

Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Detailed description

The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.

Conditions

• Aortic Aneurysm and Dissection

Interventions

Type	Name	Description
DEVICE	WeFlow-Tribranch Aortic Arch Stent Graft System	Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2023-03-06
• Last updated: 2023-08-29

Locations

4 sites across 1 country: China