Juxtarenal Abdominal Aortic AneurysmNCT05179967
Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
A study testing WeFlow-JAAA Stent Graft System in people with Juxtarenal Abdominal Aortic Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Juxtarenal Abdominal Aortic Aneurysm
- What is being tested?
- WeFlow-JAAA Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2022to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- The distance between the upper edge of the aneurysm and the lower edge of the opening of superior mesenteric artery ≥ 4mm;
- The angle between the proximal aneurysm neck and the aortic long axis near the opening of superior mesenteric artery ≤ 60 ° ;
- The aortic diameter at the opening of superior mesenteric artery ranges from 18 to 34 mm ；
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- The diameter range of the starting part of superior mesenteric artery is 5-12mm；
- The diameter range of the initial part of bilateral renal arteries is 4.5-10mm;
- Length of non bifurcated segment of superior mesenteric artery and renal artery ≥ 10mm;
- Blood vessel diameter at the bifurcation of abdominal aorta ≥ 16mm；
- The length of distal anchoring area of iliac artery ≥ 15mm;
- The diameter range of distal anchoring area of iliac artery is 8-24mm;
- With appropriate femoral artery、iliac artery and upper limb artery approaches, endovascular treatment can be performed.
- 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.
Who cannot join
- Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases);
- Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent;
- Other vascular diseases need to be intervened in the same operation (such as coronary artery and carotid artery) and the postoperative drug treatment scheme is affected;
- There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months;
- The subject has a history of abdominal aortic surgery or endovascular repair;
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- Patients with severe liver, kidney, lung and cardiac dysfunction before operation [subjects with serum creatinine level > 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.];
- Patients with acute systemic infection;
- Patients with contraindications to antiplatelet agents and anticoagulants;
- Subjects are allergic to contrast agents, anesthetics, stents and conveyor materials;
- Subjects cannot tolerate anesthesia;
- Subjects Women who are pregnant or lactating or who cannot use contraception during the trial;
- Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor);
- Subjects have participated in clinical trials of other drugs or devices in the same period;
- The researchers determine that the subjects' vascular conditions affect the revascularization of branch arteries or are combined with other diseases and are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Conditions
- Juxtarenal Abdominal Aortic Aneurysm
- Being tested
- WeFlow-JAAA Stent Graft System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-JAAA Stent Graft SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| WeFlow-JAAA Stent Graft System | Experimental | Not described Receives: Device: WeFlow-JAAA Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months after operation
Secondary outcomes (8)
Rate of all cause mortality
All cause death refers to death from any cause during the follow-up period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before discharge, 6 months, 12 months, 2 ~ 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start23 Feb 2022
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juxtarenal Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179967
- Sponsor's protocol ID
- WEIQIANG202101
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05179967
- Acronym / sponsor ID
- WEIQIANG202101
- Conditions
- Juxtarenal Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WeFlow-JAAA Stent Graft System | Experimental | Device: WeFlow-JAAA Stent Graft System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (15 listed)
- Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases);
- Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent;
- Other vascular diseases need to be intervened in the same operation (such as coronary artery and carotid artery) and the postoperative drug treatment scheme is affected;
- There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeFlow-JAAA Stent Graft SystemWeFlow-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. | Device | WeFlow-JAAA Stent Graft System |
Primary outcome
Rate of no major adverse events occurred within 30 days after operation
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.
The success rate of treatment of abdominal aortic aneurysm 12 months 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.
8 secondary outcomes
Rate of all cause mortality
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Rate of abdominal aortic aneurysm related mortality
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of serious adverse events
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of device related adverse events
Time frame: Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation
Incidence of type I or type III endoleak
Time frame: Intraoperative, before discharge, 6 months, 12 months
Incidence of aortic covered stent displacement
Time frame: 6 and 12 months after operation
Patency rate of postoperative branches
Time frame: Before discharge, 6 months, 12 months
Incidence of conversion to open surgery or secondary interventional surgery for abdominal aortic aneurysm
Time frame: Before discharge, 6 months, 12 months, 2 ~ 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-JAAA Stent Graft System in people with Juxtarenal Abdominal Aortic Aneurysm, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of no major adverse events occurred within 30 days after operation (time frame: Within 30th day after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.