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New stent graft study aims to improve aneurysm repair outcomes

NCT ID NCT05864560

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

164 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ankara University Heart Center

    Ankara, 06340, Turkey (Türkiye)

  • General University Hospital of Patras

    Pátrai, 26504, Greece

  • Laiko - University Hospital of Athens

    Athens, 11527, Greece

  • MBAL Heart and Brain EAD

    Pleven, 5804, Bulgaria

  • Papageorgiou General Hospital

    Thessaloniki, 56403, Greece

  • University Hospital for Active Treatment "Sofiamed"

    Sofia, 1797, Bulgaria

More trials for these conditions

Other studies related to the condition(s) this trial covers.