Actively Recruiting
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Led by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Updated on 2026-04-16
100
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
CONDITIONS
Official Title
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 years or older
- Diagnosis of juxtarenal or suprarenal abdominal aortic aneurysm, or type IV thoracoabdominal aneurysm with diameter greater than 5.5 cm (male) or 5.2 cm (female)
- Diagnosis of juxtarenal or suprarenal abdominal aortic aneurysm, or type IV thoracoabdominal aneurysm with aneurysm growth rate of at least 0.5 cm within 6 months
- Type IA endoleak following abdominal stent-graft implantation
- Iliac arteries morphology suitable for restoring aortic stent graft implantation
- Aortic segment proximal to aneurysm with length 20 mm or more
- Aortic segment proximal to aneurysm with diameter between 20 mm and 36 mm
- Aortic suprarenal angle of 75 degrees or more
- Expected survival greater than 2 years
You will not qualify if you...
- Age under 18 years
- Pregnancy or breastfeeding
- Allergy or hypersensitivity to materials used in the stent-graft
- Hypersensitivity or contraindication to anticoagulation or contrast used in angio CT that cannot be medically managed
- Untreatable coagulopathy
- Active infection that may cause stent-graft infection
- Creatinine level greater than 3.0 mg/dL
- Marfan syndrome or Ehlers-Danlos syndrome
- Unstable angina pectoris
- Ruptured aortic aneurysm caused by cardiac insufficiency
- Unwillingness to comply with study procedures
- Iliac arteries morphology not suitable for stent-graft implantation
- Diameter of aortic flow lumen in reno-visceral aorta greater than 34 mm
- Aortic segment proximal to celiac artery with significant thrombi, calcification, or aneurysm changes
- Aorta with significant irregular thrombi that may cause embolism ("shaggy aorta")
- Diameter of proximal kidney arteries less than 4.5 mm suitable for stenting
- Division of kidney artery suitable for stenting less than 1 cm from celiac artery, each less than 4.5 mm in diameter
- Atypical anatomy of celiac artery with separate exit of splenic and hepatic arteries
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
An Independent Clinical Hospital 2 PUM
Szczecin, West Pomeranian Voivodeship, Poland, 70-111
Actively Recruiting
Research Team
P
Pawel Rynio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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