Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHangzhou Endonom Medtech Co., Ltd.
About this trial
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
Qualifiers
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；
Disqualifiers
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;
Trial design
Treatments tested in this trial
- WeFlow-EndoPatch Aortic Endovascular Patch System
- Conventional Treatment group
Treatment groups
204 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov