A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd. for the complex abdominal aortic aneurysm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
WeFlow-JAAA Stent Graft System consists of abdominal main body of inner embedded stent graft , abdominal main bifurcation stent graft, extension stent graft and branch stent graft. The abdominal main body of inner embedded stent graft is composed of abdominal main embedded covered stent and conveyor, the abdominal main bifurcated stent graft is composed of abdominal main bifurcated stent and conveyor, the extended stent is composed of extended stent graft and conveyor, and the branch vascular stent graft is composed of branch vascular stent and conveyor. The abdominal main body of inner embedded stent graft, abdominal main bifurcation stent graft, extension stent graft and branch vascular stent graft are pre-installed in the corresponding conveyor respectively.
The General Hospital of the People's Liberation Army
Beijing, China
RECRUITINGRate of no major adverse events occurred within 30 days after operation
The main adverse events within 30 days after operation refer to all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia or necrosis of lower limbs and paraplegia within 30 days after operation. Among them, renal failure leads to lasting dialysis, renal transplantation or other fatal results. Respiratory failure leads to significantly prolonged intubation time, tracheotomy, deterioration of pulmonary function or other fatal results. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal results. Severe ischemia of lower limbs refers to new severe claudication or resting pain after operation.
Time frame: Within 30th day after operation
The success rate of treatment of abdominal aortic aneurysm 12 months after operation
Immediate postoperative technical success refers to the successful delivery of the conveyor of aortic and branch covered stents to the predetermined position, the accurate positioning and successful deployment of the stent, and the conveyor can be safely withdrawn from the body. At the end of the operation, there is no type I and III internal leakage and the branch stent is unobstructed.
Time frame: 12 months after operation
Rate of all cause mortality
All cause death refers to death from any cause during the follow-up period
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Rate of abdominal aortic aneurysm related mortality
Rate of abdominal aortic aneurysm related death refers to death caused by aneurysm rupture or surgery for aortic aneurysm
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of serious adverse events
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Serious adverse events refer to events that lead to death or serious deterioration of health status during clinical trials, including fatal diseases or injuries, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function.
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of device related adverse events
Device related adverse events refer to adverse medical events related to the use of devices during clinical trials. However, normal postoperative stress reactions, such as fever and chest and back discomfort, should be distinguished. If they are judged as normal postoperative stress reactions by the researchers, they need not be recorded in adverse events. Recording device related adverse events refers to the situation that the investigator determines to be definitely related, possibly related or unable to determine with the test device.
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of type I or type III internal leakage
The internal leakage shown by DSA or CTA was recorded. The internal leakage occurred during the operation and the adjuvant treatment is not recorded. Internal leakage after operation and untreated internal leakage in the same subject at different follow-up stages shall be calculated once.
Time frame: Intraoperative, before discharge, 6 months, 12 months
Incidence of aortic covered stent displacement
CTA was observed and recorded 6 months and 12 months after operation to check whether the stent was displaced. The main stent and branch stent were recorded and evaluated. Displacement was defined as the displacement of aortic and branch covered stents at the postoperative follow-up node more than 10mm compared with that before discharge.
Time frame: 6 and 12 months after operation
Patency rate of postoperative branches
CTA was observed and recorded before discharge, 6 months and 12 months to evaluate the revascularization of branches of renal artery and superior mesenteric artery, and whether there was occlusion, stenosis or stent thrombosis. Postoperative branch vessel stenosis ≤ 50% is regarded as unobstructed.
Time frame: Before discharge, 6 months, 12 months
Incidence of conversion to open surgery or secondary interventional surgery for abdominal aortic aneurysm
To evaluate whether the subjects were converted to open surgery or secondary interventional surgery due to abdominal aortic aneurysm.
Time frame: Before discharge, 6 months, 12 months, 2 ~ 5 years