This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.
This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor
Rate of no major adverse events within 30 days after surgery.
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
Time frame: 30 days after operation
Treatment success rate of aortic dissection 12 months after operation
The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery and no displacement of the aorta and branch stent grafts in CTA 12 months after surgery, and no type I and type III endoleaks, the branch stent was unobstructed, and no second surgical intervention occurred during the follow-up period.
Time frame: 12 months after operation
All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.
1. All-cause mortality 30 days, 6 months, and 12 months after operation. 2. Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation. 3. Incidence of serious adverse events 30 days, 6 months, and 12 months after operation. 4. The incidence of device-related adverse events 30 days, 6 months, and 12 months after operation. 5. Incidence of left upper limb ischemia 30 days, 6 months, and 12 months after operation.
Time frame: 30 days, 6 months, and 12 months after operation
The incidence of type I or type III endoleaks
Record the endoleaks shown in the postoperative DSA or CTA images. Intraoperative endoleaks and adjuvant treatment are not recorded. Endoleaks that occurred after the completion of the operation and those that were not treated in the same subject at different follow-up stages were counted once.
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Chinese PLA General Hospital
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Foshan First People's Hospital
Foshan, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
...and 19 more locations
Time frame: during operation, 30 days after operation, 6 months, 12 months
Incidence of displacement of aorta and branch stent graft
Observe and record CTA at 6 months and 12 months after operation to check the stent displacement, the main stent and branch stents are recorded and evaluated. Displacement was defined as the displacement of the node aorta and branch stent grafts by more than 10 mm compared to the 30th day after surgery.
Time frame: 6 months and 12 months after surgery
Postoperative branch vessel patency rate
Observe and record CTA on the 30th day, 6 months, and 12 months after operation to evaluate the revascularization of branch vessels, whether there is occlusion, stenosis or thrombosis in the stent. Postoperative branch vessel stenosis ≤50% is considered unobstructed.
Time frame: 30 days, 6 months, 12 months after surgery
Success rate of remodeling of aortic dissection
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.
Time frame: 30 days, 6 months, 12 months after surgery
Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection
To evaluate whether the subject was converted to thoracotomy or secondary interventional surgery due to aortic dissection.
Time frame: immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years