NCT06969729 Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
| NCT ID | NCT06969729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samodzielny Publiczny Szpital Kliniczny nr 2 PUM |
| Condition | Abdominal Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-11-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06969729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06969729 currently recruiting?
Yes, NCT06969729 is actively recruiting participants. Contact the research team at p.rynio@spsk2.szczecin.pl for enrollment information.
Where is the NCT06969729 trial being conducted?
This trial is being conducted at Szczecin, Poland.
Who is sponsoring the NCT06969729 clinical trial?
NCT06969729 is sponsored by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM. The trial plans to enroll 100 participants.