This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single 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-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
Chinese PLA General Hospital
Beijing, China
Rate of no major adverse events related to device or surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
Time frame: 30 days after surgery
Technical success rate
Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body.
Time frame: immediately after the surgery
Immediate surgery success rate
Successful delivery of the stent graft, no major adverse events related to devices or surgery.
Time frame: immediately after the surgery
The clinical success rate
Clinical success rate:12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion.
Time frame: 12 months after the surgery
The incidence rate of secondary operations within 12 months after surgery
The incidence rate of secondary operations within 12 months after surgery.
Time frame: 12 months after surgery
Adverse event rate within 12 months after surgery
Adverse event rate within 12 months after surgery.
Time frame: 12 months after surgery
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