Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
NCT05179967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2022-03-16
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
- 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.
Sponsors & Collaborators
-
Hangzhou Endonom Medtech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-23
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- China
Study Locations
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