Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
WeFlow-EndoPatch Aortic Endovascular Patch System
DeviceThe 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.
Conventional Treatment group
Other interventionDoctors prescribe conventional medicines and regular imaging tests.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: EndoPatch GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Success Rate
The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery, freedom from death or aortic dissection rupture, positive aortic remodeling, and freedom from device and/or procedure related reinterventions.
Time frame
12 monthsSecondary outcomes
1
Immediate Technical Success in EndoPatch Group
Immediate technical success is defined as successful delivery of the endopatch conveyors to their predetermined positions, accurate positioning and successful deployment of the patch, safe removal of the delivery device outside the body, and no conversion to thoracotomy.
Time frame
Immediately after the surgery2
Entry Tears Closure Success in EndoPatch Group
Entry tears closure success is defined as absence of TL or FL backflow through the tears on CTA.
Time frame
30 days, 6 months, and 12 months3
False Lumen Thrombosis of the Descending Thoracic Aorta
False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Time frame
30 days, 6 months, and 12 months4
True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta
True lumen diameter, false lumen diameter and maximum total diameter of the descending thoracic aorta observed by postoperative CTA review.
Time frame
30 days, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov