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

Launched by SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 2 PUM · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment for patients with complex abdominal aortic aneurysms (AAAs), which are bulges in the main artery leading from the heart to the rest of the body. Researchers want to compare a special stent-graft (a tube used to support the artery) made using 3D printing technology to custom-made devices. The goal is to see if the 3D printed stent-graft is just as effective and safe as the traditional options in treating these aneurysms.

To be eligible for the trial, participants need to be at least 18 years old and have specific types of abdominal aneurysms that are larger than certain sizes or growing quickly. The trial is open to both men and women, and currently, it is actively recruiting participants. If someone joins the study, they can expect careful monitoring and support throughout the treatment process. It's important to note that there are certain health conditions that may disqualify someone from participating, such as severe allergies to the materials used in the stent or other serious medical issues.

Gender

ALL

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