Initial Experience with Fenestrated Physician-Modified Stent Grafts Using 3D Aortic Templates.
Paweł Rynio, Tomasz Jedrzejczak, Anita Rybicka...
https://pubmed.ncbi.nlm.nih.gov/35456273Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06969729
Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial
Led by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Updated on 2026-04-16
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the comparison between physician-modified stent-grafts created using patient-specific 3D-printed aortic templates and commercially manufactured custom-made fenestrated stent-grafts for treating complex abdominal aortic aneurysms, including juxtarenal, pararenal, thoracoabdominal aneurysms, and type IA endoleak. This randomized, multicenter, open-label study aims to evaluate the efficacy and safety of these two approaches in patients with these specific aortic conditions. Participants will be randomly assigned to one of two groups: Arm A will receive the innovative angiosurgery treatment with physician-modified stent-grafts guided by 3D-printed templates, and Arm B will receive the standard procedure involving implantation of custom-made fenestrated stent-grafts via an endovascular approach. The study includes a screening phase lasting up to 28 days, followed by two hospitalizations during which the angiosurgery interventions occur. After intervention, participants will have two follow-up visits, with safety monitoring continuing for 12 months. During the study, participants will undergo several assessments including aorta evaluation by angio CT at screening, during the first hospitalization, and at 30-day and 12-month follow-ups. Researchers will monitor survival rates at 30 days and 1 year without aortic rupture, along with other outcomes such as aneurysm growth, cardiovascular events, renal function changes, reintervention rates, and overall mortality. The study aims to gather detailed efficacy and safety data with a total follow-up period of one year post-procedure.
CONDITIONS
Brief Title
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Diagnosis of juxtarenal or suprarenal abdominal aortic aneurysm, or type IV thoracoabdominal aneurysm with diameter >5.5cm (male) or >5.2cm (female)
- Aneurysm growth rate of 0.5cm or more in 6 months for those with juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aneurysm
- Type IA endoleak after abdominal stent-graft implantation
- Iliac arteries morphology suitable for restoration with aortic stent graft implantation
- Aortic segment proximal to aneurysm with length 20mm or more and diameter between 20mm and 36mm
- Aortic suprarenal angle of 75 degrees or more
- Expected survival of more than 2 years
You will not qualify if you...
- Age under 18 years
- Pregnancy or breastfeeding
- Allergy or hypersensitivity to stent-graft materials
- Hypersensitivity or contraindication to anticoagulation or contrast agents 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
- Aortic flow lumen diameter in reno-visceral aorta greater than 34mm
- Proximal aortic section to celiac artery with significant thrombi, calcification, or aneurysm changes
- Presence of significant irregular thrombi in aorta that may cause embolism ("shaggy aorta")
- Diameter of proximal kidney arteries less than 4.5mm suitable for stenting
- Division of kidney artery within 1cm of celiac artery with diameters less than 4.5mm
- Atypical anatomy of celiac artery with separate exit of splenic and hepatic arteries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including angio CT
Treatment
Duration - From randomization until completion of second hospitalization
Participants undergo two hospitalizations with angiosurgery interventions to implant either a physician-modified fenestrated stent-graft using a 3D-printed aortic template or a custom-made fenestrated stent-graft via an endovascular approach.
2 hospitalizations for angiosurgery interventions
Safety Follow-up
Duration - 12 months
Participants are monitored for safety and clinical outcomes following the angiosurgery interventions.
2 follow-up visits including assessments at 30 days and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
An Independent Clinical Hospital 2 PUM
Szczecin, West Pomeranian Voivodeship, Poland, 70-111
Actively Recruiting
Loading map...
Research Team
P
Pawel Rynio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here