Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHangzhou Endonom Medtech Co., Ltd.

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

Treatment groups

90 Participants
are divided into 1 treatment group