Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WeFlow-JAAA Stent Graft System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WeFlow-JAAA Stent Graft System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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. | 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 endoleak and the branch stent is unobstructed. | 12 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all cause mortality | All cause death refers to death from any cause during the follow-up period | Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation |
| Rate of abdominal aortic aneurysm related mortality |
Not provided
Inclusion Criteria:
Age 18-80 years old, regardless of gender;
Subjects who were diagnosed with Juxtarenal and Pararenal abdominal aortic aneurysms and needed to reconstruct the blood supply of superior mesenteric artery and bilateral renal arteries;
Have appropriate vascular conditions, mainly including:
Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of the People's Liberation Army | Beijing | China |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: new version | Oct 16, 2022 | Jun 25, 2026 | Prot_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Rate of abdominal aortic aneurysm related death refers to death caused by aneurysm rupture or surgery for aortic aneurysm
| Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation |
| Incidence of serious adverse events | 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. | 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. | Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation |
| Incidence of type I or type III endoleak | 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. | 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. | 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. | 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. | Before discharge, 6 months, 12 months, 2 ~ 5 years |