RecruitingNot ApplicableNCT07658651

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

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


Sponsor

Hangzhou Endonom Medtech Co., Ltd.

Enrollment

256 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Thoracic Endovascular Aortic Repair(TEVAR) and a medical device called WeFlow-EndoSeal™ Aorta Vascular Plug System for people with aortic dissection type b. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEWeFlow-EndoSeal™ Aorta Vascular Plug System

WeFlow-EndoSeal™ Aorta Vascular Plug System

PROCEDUREThoracic Endovascular Aortic Repair(TEVAR)

Thoracic Endovascular Aortic Repair(TEVAR)


Locations(1)

First Medical Center of The Chinese PLA General Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07658651


Related Trials