3D printing may help doctors fix dangerous aortic bulges more safely
NCT ID NCT06969729
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.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: 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.
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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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An Independent Clinical Hospital 2 PUM
RECRUITINGSzczecin, West Pomeranian Voivodeship, 70-111, Poland
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 a tailored stent graft tame complex aortic aneurysms?
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- A simple gas flush before aortic repair might prevent strokes
- 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