NCT05179967

Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)

Guo's visceRal artEries Reconstruction :The Prospective, Multiple Center, Objective Performance Criteria Clinical Trial About the sAfTy and Efficacy of WeFlow-JAAATM Stent Graft System.(GREAT Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd. for the complex abdominal aortic aneurysm.

Conditions

• Juxtarenal Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	WeFlow-JAAA Stent Graft System	WeFlow-JAAA Stent Graft System consists of abdominal main body of inner embedded stent graft , abdominal main bifurcation stent graft, extension stent graft and branch stent graft. The abdominal main body of inner embedded stent graft is composed of abdominal main embedded covered stent and conveyor, the abdominal main bifurcated stent graft is composed of abdominal main bifurcated stent and conveyor, the extended stent is composed of extended stent graft and conveyor, and the branch vascular stent graft is composed of branch vascular stent and conveyor. The abdominal main body of inner embedded stent graft, abdominal main bifurcation stent graft, extension stent graft and branch vascular stent graft are pre-installed in the corresponding conveyor respectively.

Timeline

• Start date: 2022-02-23
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2022-01-06
• Last updated: 2022-03-16

Locations

1 site across 1 country: China