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

RecruitingNAAges 18 Years - anyAllSamodzielny Publiczny Szpital Kliniczny nr 2 PUM
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Female and male subjects age โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ20mm * Diameter 20mm-36mm * Aortic suprarenal angle โ‰ค75 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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What it tests

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

1 site
An Independent Clinical Hospital 2 PUM
Szczecin, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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