A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
Patients aged 18 to 80 years old;
Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
Experienced systemic infection during past three months;
Neck surgery was performed within 3 months;
Previous endovascular interventional treatment involving the aortic arch was performed;
Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
Single group
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
DeviceThe WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.
Rate of all-cause mortality and major stroke within 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
Rate of immediate technical success following surgery
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, and the absence of Type I and III endoleaks and all branching stents patency per imaging studies conducted at the end of the procedure .
Rate of aortic aneurysm progression under control
Aortic aneurysm progression under control is defined as maximum increase in the diameter of the aortic aneurysm was ≤ 5 mm when compared with preoperative aortic aneurysm as of a 12-month postoperative CTA review.
Incidence of Type I or Type III endoleak
Endoleak detected by DSA or CTA during operation and at 1, 6, and 12 months after operation. Intraoperative endoleaks subject to adjuvant treatment are not recorded. Endoleaks occurring after the completion of the procedure followed by one or more endoleaks occurring in the same subject at different follow-up stages that were not treated are counted as a single instance.
Incidence of aortic covered stent graft displacement
CTA examination will be performed at 6 months, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Displacement is defined as a nodal aortic or branching stent graft displacement of more than 10 mm compared with that at postoperative day 30.
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