Can a new stent graft reinforce a weakened aorta and prevent rupture?
NCT ID NCT07754240
First seen Aug 10, 2026 · Last updated Aug 19, 2026 · Updated 6 times
Summary
This trial is testing a new stent graft system designed to treat abdominal aortic aneurysms—a bulging, weakened area in the main artery. The device is placed inside the aorta to reinforce the wall and prevent rupture. The study includes adults with infrarenal abdominal aortic aneurysms who are suitable for endovascular repair. Researchers are evaluating how safe the device is in the first 30 days and how well it works over 12 months, looking at factors like aneurysm growth, device movement, and the need for further procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ankura II Abdominal Aortic Stent Graft System (a device implanted to reinforce the weakened aorta wall)
- What this could lead to
- If successful, this could offer a safer, more effective minimally invasive option for repairing abdominal aortic aneurysms, potentially reducing complications and improving long-term outcomes.
- What could go wrong
- This is an early-stage study with a small number of patients, so results may not apply to everyone. Risks include bleeding, infection, device migration, or the aneurysm leaking or rupturing.
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
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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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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- 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. 18 years ≤ age ≤80years, no gender limitation. 2. Patients diagnosed with infrarenal abdominal aortic aneurysm and should meet at least one of the following conditions: 1. The maximum diameter of abdominal aortic aneurysm is 55 mm or more in male patients or 50 mm or more in female patients; 2. The maximum diameter of abdominal aortic aneurysm has increased by more than 5 mm in the last 6 months or 10 mm in the last 1 year; 3. Abdominal aortic aneurysm oppresses important organs and viscera and causes symptoms (such as abdominal pain, lower back pain, etc.). 3. Anatomical criteria: * Diameter of the proximal abdominal aortic aneurysm neck ranges from 17 mm to 33 mm; * Length of the proximal abdominal aortic aneurysm neck ≥ 10 mm; * Angle of the proximal abdominal aortic aneurysm neck ≤ 75 degrees; * At least one side of the iliac artery anchorage zone has a diameter of 20 to 25 mm, while the other side of the iliac artery anchorage zone could be 7 to 25 mm; * Length of the bilateral iliac artery anchorage zone ≥ 15mm; * Adequate iliac or femoral vessel access 4. Patients who are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent form, and are willing to complete the follow-up visits as per the protocol. Exclusion Criteria: 1. Patients with ruptured or leaking abdominal aortic aneurysm; 2. Patients with infectious abdominal aortic aneurysm; 3. Patients with abdominal aortic dissection; 4. Patients with traumatic aortic disease; 5. Patients with severe stenosis, calcification or mural thrombus in the stent anchoring zone likely to cause difficult covered stent apposition or the impact on stent patency; 6. Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery; 7. Patients with accessory renal artery original from abdominal artery; 8. Patients who have undergone abdominal aortic surgery or endovascular intervention; 9. Patients with stroke (Except for TIA), myocardial infarction or unstable angina within 3 months; The unstable angina is characterized by: progressively increased angina symptoms, new onset of angina while resting or during the night, or prolonged angina duration 10. Patients with allergies to contrast agents, stent graft and delivery system materials (i.e., nitinol, polyester, PTFE, nylon polymer materials); 11. Patients with allergies or contraindications to anticoagulant and antiplatelet drugs; 12. Patients with abnormal hepatic and renal functions before operation (ALT or AST exceeding five times the upper limit of normal; STB exceeding two times the upper limit of normal; baseline serum creatinine exceeding 2.0 mg/dL (approximately 176.8 μmol/L)); 13. Patients who have undergone major surgery within 30 days prior to the procedure, or who are scheduled to undergo major surgery within 30 days following the procedure; 14. Patients have morbid obesity (BMI of \>40.0 kg/m2) or other clinical conditions that inhibit visualization of the aorta; 15. Patients with systemic or localized infection likely to increase the risk of endovascular graft infection; 16. Patients with connective tissue diseases related to the aorta, such as Marfan's syndrome; 17. Patients with life expectancy of less than 1 year; 18. Female patients who are in pregnancy or lactation, or plan to become pregnant; 19. Patients who are not suitable for endovascular treatment according to the investigator's judgement; 20. Patients who are participating in other device or drug clinical investigational studies.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MBAL Heart and Brain EAD
RECRUITINGPleven, Bulgaria
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