A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
148
All patients received endovascular surgery using fabulous stent graft system
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Number of patients with no incidence of major surgical or device related adverse events rate
Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device
Time frame: within 30 days after surgery
Clinical success rate
Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection
Time frame: 12 months after surgery
adverse event rate
Time frame: within 12 months after surgery
Immediate delivery success rate
The stent graft system was successfully transported to the correct position and released successfully
Time frame: immediately after the surgery
Immediate operation successful rate
After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well
Time frame: immediately after the surgery
Endoleak rate
Time frame: within 12 months after surgery
Secondary surgical treatment rate
Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation
Time frame: within 12 months after surgery
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Chinese People's Liberation Army General Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Hainan Provincial People's Hospital
Haikou, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
...and 14 more locations