New stent graft study aims to improve aneurysm repair outcomes
NCT ID NCT05864560
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 164 people with abdominal aortic aneurysm who receive the Ankura stent graft system, a device placed inside the aorta to reinforce the weakened area. Researchers will track major complications and treatment success over 12 months. The goal is to see how well the device works in everyday medical practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ankura stent graft system (a device implanted to reinforce the weakened aorta)
- What this could lead to
- If successful, this could confirm that the Ankura stent graft system is a safe and effective option for repairing abdominal aortic aneurysms, reducing the need for open surgery.
- What could go wrong
- This is a post-market study, so the device is already approved; however, real-world results may reveal complications like device migration or re-intervention. The study is observational and not randomized, so comparisons to other treatments are limited.
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.
- Participants
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164 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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Sep 2028
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.
Who is studied
Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.
- Ages
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18 to 85 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. Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascular aortic repair; 2. Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent Graft IFU requirements, which indicated by the following: 1. Adequate iliac/femoral access vessel that is compatible with the required delivery system. 2. Non-aneurysmal proximal aortic neck length ≥15mm. 3. Non-aneurysmal proximal aortic neck diameter of 18-32mm. 4. Proximal aortic neck angulation ≤ 60°. 5. Distal iliac artery anchorage zone ≥15mm. 6. Distal iliac artery diameter of i. 8-22 mm (for Ankura™ AAA and Cuff Stent Graft Systems), OR ii. 10-16 mm (for Ankura™ AUI Stent Graft System). 7. Morphology suitable for endovascular repair. 3. Patient could understand the purpose of the clinical trial, agrees to comply with the requirements of the study including the 3-year follow-up, and signed the patient informed consent, will participate in the study. Exclusion Criteria: 1. Age\<18 years or Age\>85 years; 2. Patients' life expectancy \< 1 year; 3. Pregnant or plan to be pregnant or breast feeding; 4. Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent Graft Systems, or in Ankura™ AUI Stent Graft system IFU: 1. Patient with acute systemic infection; 2. Patient with mesenteric blood flow mainly supplied by the inferior mesenteric artery; 3. Patient with accessory renal artery original from abdominal artery; 4. Patient who has allergic reaction to the device; 5. Patient who is not suitable for endovascular repair in vascular morphology; 6. Patient who cannot tolerate contrast agents due to renal insufficiency; 7. Patient who is allergic to contrast agent; 8. Patient's aneurysms neck has thrombus; 9. Non-aneurysmal proximal aortic neck length \<15mm; 10. Non-aneurysmal proximal aortic neck diameter \<18mm or \>32mm; 11. Proximal aortic neck angulation \> 60°; 12. Distal iliac artery anchorage zone \<15mm; 13. Distal iliac artery diameter: i. For Ankura™ AAA and Cuff Stent Graft Systems: \<8mm or \>22mm, OR ii. For Ankura™ AUI Stent Graft system: \<10mm or \>16mm. 5. Patient with traumatic aortic injury; 6. Patient with uncorrectable coagulopathy; 7. Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome; 8. Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms; 9. Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity. 10. Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases. 11. Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints. 12. Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
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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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Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
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Ankara University Heart Center
Ankara, 06340, Turkey (Türkiye)
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General University Hospital of Patras
Pátrai, 26504, Greece
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Laiko - University Hospital of Athens
Athens, 11527, Greece
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MBAL Heart and Brain EAD
Pleven, 5804, Bulgaria
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Papageorgiou General Hospital
Thessaloniki, 56403, Greece
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University Hospital for Active Treatment "Sofiamed"
Sofia, 1797, Bulgaria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stent graft tested for keeping kidney and gut arteries open during aneurysm repair
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- Can a stent-graft keep aortic aneurysms in check for years? a long-term follow-up study aims to find out.
- Aneurysm repair may stiffen arteries — a study asks what that means for the heart
- Rehab after aneurysm surgery: could a 3-Week program boost heart and lung fitness?
- Nerve block may offer safer pain relief after major aortic surgery