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

Locations

20
Beijing Anzhen Hospital, Capital Medical University Beijing China
Chinese PLA Gencral Hosptial Beijing China
The First Hospital of Jilin University Changchun China
Xiangya Hospital of Central South University Changsha China

Sponsors and collaborators

Hangzhou Endonom Medtech Co., Ltd.

Lead sponsor