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Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)

NCT06945809 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-04-30

No results posted yet for this study

Summary

A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)

Conditions

  • Aortic Dissection
  • Distal Entry Tear

Interventions

DEVICE

WeFlow-EndoPatch Aortic Endovascular Patch System

The WeFlow-EndoPatch Aortic Endovascular Patch System for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.

OTHER

Conventional Treatment group

Doctors prescribe conventional medicines and regular imaging tests.

Sponsors & Collaborators

  • Hangzhou Endonom Medtech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Guo · Chinese PLA Gencral Hosptial

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-10-31
Completion
2032-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945809 on ClinicalTrials.gov