Evaluation of a 3D-Printed Stent-Graft for Aortic Aneurysms

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

This study is testing a new 3D-printed stent-graft to see if it works better and is safer than standard devices for treating complex abdominal aortic aneurysms in about 100 patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM (other)
• Locations: 1 site (Szczecin, West Pomeranian Voivodeship)
• Trial ID: NCT06969729 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the efficacy and safety of a physician-modified stent-graft created using 3D printing technology against standard custom-made devices for treating complex abdominal aortic aneurysms. It is a randomized, multicenter, open-label study involving approximately 100 patients, who will be assigned to either the innovative intervention or the standard procedure. The study includes a screening phase, intervention phase, and a 12-month safety follow-up to assess outcomes. Randomization will help minimize bias and ensure balanced characteristics among treatment groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific types of abdominal aortic aneurysms or endoleaks that meet the study criteria.

Not a fit: Patients under 18, pregnant or breastfeeding women, and those with allergies to stent materials or contraindications to anticoagulation will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and tailored treatment option for patients with complex aortic aneurysms.

How similar studies have performed: While the use of 3D printing in medical devices is gaining traction, this specific approach to treating aortic aneurysms is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Szczecin, West Pomeranian Voivodeship

• An Independent Clinical Hospital 2 PUM — Szczecin, West Pomeranian Voivodeship, Poland (RECRUITING)

Study contacts

• Study coordinator: Pawel Rynio

Conditions: Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Type IA Endoleak, AAA, physician-modified stent-graft, custom-made device