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New stent graft aims to fix Hard-to-Reach aneurysms while saving key arteries
NCT ID NCT05179967
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This trial tests a special stent graft system designed to repair a complex type of abdominal aortic aneurysm that involves the arteries to the kidneys and gut. The device is placed inside the aorta using a minimally invasive procedure, aiming to seal the aneurysm while keeping blood flowing to vital organs. The study includes 106 adults aged 18 to 80 who need this type of repair. Researchers will check how safe the device is within 30 days and how well it works over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WeFlow-JAAA Stent Graft System
- What this could lead to
- If successful, this device could offer a less invasive way to treat complex abdominal aortic aneurysms that are hard to reach with standard surgery.
- What could go wrong
- This is an early-stage trial with 106 participants, so results may not apply to everyone. Risks include serious events like kidney failure, stroke, or bowel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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106 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years old, regardless of gender; 2. 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; 3. 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 ; * 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. 4. 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: 1. Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability; 2. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases); 3. Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent; 4. 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; 5. There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months; 6. The subject has a history of abdominal aortic surgery or endovascular repair; 7. Patients with severe liver, kidney, lung and cardiac dysfunction before operation \[subjects with serum creatinine level \> 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.\]; 8. Patients with acute systemic infection; 9. Patients with contraindications to antiplatelet agents and anticoagulants; 10. Subjects are allergic to contrast agents, anesthetics, stents and conveyor materials; 11. Subjects cannot tolerate anesthesia; 12. Subjects Women who are pregnant or lactating or who cannot use contraception during the trial; 13. Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor); 14. Subjects have participated in clinical trials of other drugs or devices in the same period; 15. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The General Hospital of the People's Liberation Army
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.