Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch … (NCT06385379) | Clinical Trial Compass
RecruitingNot Applicable
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
China90 participantsStarted 2024-06-30
Plain-language summary
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)
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Showing a suitable vascular condition, including:
✓. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
✓. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.
Exclusion criteria
✕. Experienced systemic infection during past three months;
✕. Neck surgery was performed within 3 months;
✕. Previous endovascular interventional treatment involving the aortic arch was performed;