Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
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- Who runs it
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
- Trial code
- NCT06969729
- Record updated
- 16 April 2026
- Original description
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysmRead full original descriptionShow less
Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
Inclusion: 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: Allergy and hypersensitivity to matherials of which the stent- graft is composed; Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically; Active infection which might cause stent - graft infection; Marphan syndrome, Ehlers - Denlos syndrome; Unstable angina pectoris; Raptured aortic aneurysm caused by cardiac insufficiency; Creatinine level > 3.0mg/dL; Female and male subjects age <18; Pregnancy and breast feeding; Coagulopathy which cannot medically treated; Unwillingness to comply with protocol procedures; Iliac arteries morphology adequate for stent-graft implantation; The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm; Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm; Aorta with significant number of irregular thrombi which may lead to embolism ("shaggy aorta"); Diameter of proximal kidney arteries which is exercisable to stenting <4.5mm; 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; Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery.