Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT06945809

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

Conditions: Aortic Dissection, Distal Entry Tear

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 216
Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Location: Chinese PLA General Hospital Beijing Beijing Municipality

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)

Eligibility Criteria

Inclusion Criteria: * Patients aged 18 to 80 years old, no gender limitation; * The patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal; * The maximum diameter of the descending thoracic aorta is 3.5-5cm; * The number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm; * With appropriate artery approaches, endovascular treatment can be performed; * Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements. Exclusion Criteria: * Rupture or threatened rupture of aortic dissection; * Proximal type I internal leakage after aortic repair; * New distal SINE; * Abdominal aortic dissection aneurysm diameter ≥5 cm; * The edge of the tear from the opening of celiac trunk is\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06945809). StuddyBuddy aggregates publicly available trial information.