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Recruiting Not applicable

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology

NCT06969729 · tracked via the Priya Life Science Poland tracker
Sponsor
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Phase
Not applicable
Started
2022-11-01
Last updated
2026-04-16

Condition(s) studied

Abdominal Aortic AneurysmJuxtarenal Abdominal Aortic AneurysmPararenal Abdominal Aortic AneurysmThoracoabdominal Aortic AneurysmType IA Endoleak

Investigational drug(s) / intervention(s)

Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)

Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided): Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants Surviving at 1 Year Without Aortic Rupture — 1 year
    Rupture - free one year survival. The number of participants who remain alive and free from aortic rupture at 1 year following stent-graft implantation. Rupture will be defined as radiologically confirmed loss of aortic wall integrity with associated clinical symptoms.
  • Number of Participants Surviving at 30 Days Post-Procedure (Perioperative Survival) — 30 days
    The number of participants who are alive 30 days after the stent-graft procedure. Deaths from any cause within 30 days post-implantation will be counted.

Trial sites (1)

FacilityCityRegionStatus
An Independent Clinical Hospital 2 PUM Szczecin West Pomeranian Voivodeship Recruiting

More Samodzielny Publiczny Szpital Kliniczny nr 2 PUM trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06969729 on ClinicalTrials.gov ↗ ← All trials in Poland