About this trial
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)
Eligibility criteria
Qualifiers
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;
Disqualifiers
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 );
Trial design
Treatments tested in this trial
- WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system