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RECRUITING
NCT07658651
NA

WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection

Sponsor: Hangzhou Endonom Medtech Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. The main questions it aims to answer are: Does WeFlow-EndoSeal™ combined with TEVAR provide superior therapeutic efficacy versus standard TEVAR alone for Stanford type B aortic dissection? Does the combined intervention maintain a comparable safety profile relative to standard TEVAR alone? Researchers will compare the test arm (WeFlow-EndoSeal™ Aorta Vascular Plug System plus TEVAR) with the control arm (standard TEVAR alone), with subjects randomized at a 1:1 ratio, to see if the add-on device enhances treatment outcomes without elevating safety risks. Participants will: Be randomly assigned to either the test arm or the control arm with equal probability, free from subjective influence of investigators or participants Undergo the corresponding standardized endovascular procedure per their group allocation Complete protocol-specified clinical follow-ups and imaging assessments for efficacy and safety evaluation

Official title: A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Safety and Efficacy of the WeFlow-EndoSeal™ Aorta Vascular Plug System Combined With TEVAR for the Treatment of Stanford Type B Aortic Dissection

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2026-06-01

Completion Date

2032-03-01

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DEVICE

WeFlow-EndoSeal™ Aorta Vascular Plug System

WeFlow-EndoSeal™ Aorta Vascular Plug System

PROCEDURE

Thoracic Endovascular Aortic Repair(TEVAR)

Thoracic Endovascular Aortic Repair(TEVAR)

Locations (1)

First Medical Center of The Chinese PLA General Hospital

Beijing, Beijing Municipality, China