NCT06969729

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm

Detailed description

This is randomized, multicenter, open-label, 2 -arm Study to evaluate the efficacy and safety in stent-graft application of arm A and Arm B in patients with juxtarenal or pararenal abdominal aortic aneurysm, thoracic-abdominal aneurysm type IV or type IA endoleak. Approximately 100 eligible patients will be randomized in a 1:1 ratio into 2 arms (n=50 in each arm) Arm A treated with innovative angiosurgery intervention Arm B standard procedure Study will use an Interactive Web Response System (IWRS) for randomization. Randomization will be used to minimize bias in the assignment of subjects to treatment groups, to increase the likelihood that known and unknown subject attributes (e.g. demographic and baseline characteristics) are evenly balanced, and to enhance the validity of statistical comparisons across treatment groups. Subjects will be randomized based on following stratification: • Site • Aneurysm class Subject participation will include a Screening Phase, Intervention Phase, Safety follow-up and End of Study. The screening phase will last up to 28 days before the therapeutic intervention periods starts (two hospitalizations finished with 2 angio surgery intervention) during which the subject's eligibility and baseline characteristics will be determined. The therapeutic intervention will last from randomization until second hospitalization will end with angio surgery intervention). There will be 2 follow up visits. Safety follow up will lasts 12 months. Aorta assessment by angio CT will be performed at screening, intervention period at hospitalization no. 1 and in 30 day follow up, 12 month follow up

Conditions

• Abdominal Aortic Aneurysm
• Juxtarenal Abdominal Aortic Aneurysm
• Pararenal Abdominal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm
• Type IA Endoleak

Interventions

Type	Name	Description
PROCEDURE	Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)	Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-05-14
• Last updated: 2026-04-16

Locations

1 site across 1 country: Poland