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Study identifier: NCT07658651 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Aortic Dissection Type B  ·  Sponsor: Hangzhou Endonom Medtech Co., Ltd.

PhaseNA
Planned participants256
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Huang Jin Jing  ·  13916287877  ·  jingjing.huang@endonom.com

Always discuss trial participation with your own doctor first.

Locations (1)

First Medical Center of The Chinese PLA General HospitalBeijing, Beijing Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07658651