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3D printing may help doctors fix dangerous aortic bulges more safely

NCT ID NCT06969729

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways to treat complex abdominal aortic aneurysms (a bulging blood vessel in the belly). One method uses a custom-made stent-graft, the other uses a stent-graft shaped with the help of a 3D-printed model of the patient's aorta. The goal is to see which approach leads to better survival and fewer complications. About 100 adults with large or fast-growing aneurysms will take part.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: Female and male subjects age ≥ 18 2. Subject need to meet one of the following criteria: * Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \>5.5cm (male) and 5.2cm (female) * Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoraco-abdominal aneurysm with aneurysm growth rate ≥ 0.5cm during 6 months * Type IA endoleak of post-implantation of abdominal stent- graft 3. Iliac arteries morphology with aortic stent graft implantation to be restored 4. Aortic segment which is proximal to aneurysm * Length ≥20mm * Diameter 20mm-36mm * Aortic suprarenal angle ≤75 degrees 5. Survival \> 2 years Exclusion Criteria: 1. Female and male subjects age \<18 2. Pregnancy and breast feeding 3. Allergy and hypersensitivity to matherials of which the stent- graft is composed 4. Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically 5. Coagulopathy which cannot medically treated 6. Active infection which might cause stent - graft infection 7. Creatinine level \> 3.0mg/dL 8. Marphan syndrome, Ehlers - Denlos syndrome 9. Unstable angina pectoris 10. Raptured aortic aneurysm caused by cardiac insufficiency 11. Unwillingness to comply with protocol procedures 12. Iliac arteries morphology adequate for stent-graft implantation 13. The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm 14. Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm 15. Aorta with significant number of irregular thrombi which may lead to embolism ("shaggy aorta") 16. Diameter of proximal kidney arteries which is exercisable to stenting \<4.5mm 17. Devision of kidney artery which is exercisable to stenting in the distance of \<1cm of celiac artery, each of them is is in \<4.5mm in diameter 18. Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • An Independent Clinical Hospital 2 PUM

    RECRUITING

    Szczecin, West Pomeranian Voivodeship, 70-111, Poland

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