The General Hospital of the People's Liberation Army
Beijing, China
NCT Number: NCT05179967
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 30th day 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: 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predetermined position, the accurate positioning and successful deployment of the stent, and the conveyor can be safely withdrawn from the body.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 endoleak and the branch stent is unobstructed.
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
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 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
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
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: Intraoperative, before discharge, 6 months, 12 months
The endoleak shown by DSA or CTA was recorded. The endoleak occurred during the operation and the adjuvant treatment is not recorded. endoleak after operation and untreated endoleak in the same subject at different follow-up stages shall be calculated once.
Time frame: 6 and 12 months after operation
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: Before discharge, 6 months, 12 months
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, 2 ~ 5 years
To evaluate whether the subjects were converted to open surgery or secondary interventional surgery due to abdominal aortic aneurysm.
Hangzhou Endonom Medtech Co., Ltd.
Industry
Guo's visceRal artEries Reconstruction :The Prospective, Multiple Center, Objective Performance Criteria Clinical Trial About the sAfTy and Efficacy of WeFlow-JAAATM Stent Graft System.(GREAT Study)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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