To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm
The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Endovascular treament in patients with aortic arch dissection and aneurysm by WeFlow-Tribranch Aortic Arch Stent Graft System
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality, China
RECRUITINGNanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGAll-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
Time frame: 12 months post-intervention
Aortic-related mortality within 12 months post operation.
Refers to mortality caused by a ruptured aortic dissection/aneurysm or endovascular interventional treatment.
Time frame: within 12 months post operation
Aortic remodeling results.
Compare the results of CTA before operation and on the 30th day, 6th month and 12th month after operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled,or CTA reexamination 12 months after operation showed that the maximum diameter of Aortic aneurysm increased by ≤ 5 mm compared with that before operation.
Time frame: 1 month, 6 months and 12 months post-intervention
Major adverse events occurring within 30 days after surgery.
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
Time frame: within 30 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGIncidence of severe adverse events.
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time frame: within 12 months post-intervention