First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms

This clinical trial evaluates the safety and feasibility of the A3-Shield implant for stabilising small abdominal aortic aneurysms in adult patients. The study enrolls men and women with small, asymptomatic infrarenal abdominal aortic aneurysms who are eligible for an elective catheter-based procedure. The trial aims to determine whether implantation of the A3-Shield device is technically feasible and whether it is associated with mechanical immobilization of the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device. Participants will undergo implantation of the A3-Shield device and attend scheduled follow-up visits that include clinical assessments and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.

NCT Number	NCT07330752
Lead Sponsor	Angiolutions GmbH
Conditions	Aneurysm, Abdominal Aortic
Enrollment	12 participants
Start Date	2025-11-28
Primary Completion	2026-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-01-09