Conventional TEVAR Versus FABULOUS RCT
NCT06740565 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392
Last updated 2024-12-18
Summary
For High-risk Type B aortic dissections, a multicenter, prospective, randomized controlled study is conducted to compare the clinical outcomes of conventional proximal endovascular repair (TEVAR) alone versus the Fabulous system which includes a proximal stent graft with a distal bare metal stent implanted. The study aims to determine the optimal intervention method for such population.
Conditions
- Type B Aortic Dissection
Interventions
- PROCEDURE
-
thoracic endovascular aortic repair
stent-graft implanted to seal the proximal entry tear of type B aortic dissection
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2027-02-01
- Completion
- 2029-02-01
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