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)
This study is a multicenter, prospective, superiority, randomized controlled trial about the safety and efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System. It is expected to complete the implantation of 204 patients in 15 centers within 24 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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.
Doctors prescribe conventional medicines and regular imaging tests.
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 months
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 surgery
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 months
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 months
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 months
Device and/or Procedure Related Reinterventions
Time frame: 30 days, 6 months, and 12 months
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No major adverse events within 30 days after surgery
Major adverse events within 30 days after surgery refer to all-cause death, aortic dissection rupture, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation.
Time frame: Before discharge, 30 days after surgery
Patch Fall-off in EndoPatch Group
Time frame: 30 days, 6 months, and 12 months
All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events
Time frame: 30 days, 6 months, and 12 months