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RECRUITING

NCT06969729

PHASE2/PHASE3

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

Sponsor: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

View on ClinicalTrials.gov

Summary

the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm

Official title: Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-11-01

Completion Date

2027-04-30

Last Updated

2025-05-14

Healthy Volunteers

Conditions

Abdominal Aortic Aneurysm Juxtarenal Aortic Aneurysm Thoracoabdominal Aneurysm Endoleak

Interventions

PROCEDURE

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.

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

Locations (1)

An Independent Clinical Hospital 2 PUM

Szczecin, West Pomeranian Voivodeship, Poland