Pilot Study to Test Safety and Effectiveness of the A3-Shield Device for Stabilizing Small Abdominal Aortic Aneurysms in Adults

What this Trial Is About

Researchers are evaluating the safety and feasibility of the A3-Shield implant in adults with small, asymptomatic infrarenal abdominal aortic aneurysms. This trial addresses the lack of treatments that prevent the growth of small abdominal aortic aneurysms, which often enlarge over time and may require risky surgical repair. The study focuses on whether the A3-Shield device can mechanically stabilize the aneurysm neck and reduce harmful pulse wave forces that contribute to aneurysm enlargement. Participants receive a catheter-based implantation of the A3-Shield device guided by fluoroscopy. After the procedure, they attend scheduled follow-up visits which include clinical exams and imaging tests like ultrasound and computed tomography. This trial does not include randomization or a control group and aims to gather early data on the devices performance and safety. During the study, participants will undergo assessments of safety outcomes including major adverse events within 30 days and longer-term safety up to 24 months. Effectiveness measures such as successful aneurysm treatment, aneurysm size stability or shrinkage, and immobilization of the aneurysm neck are evaluated at multiple time points. Participants must be able to return for follow-up visits, and the total study duration includes assessments up to two years after implantation.

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