PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective A3- Shield System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase
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.
⁃ IC1. Male and female subjects ≥ 18 years at the time of screening. Female subjects must be of non-childbearing potential or otherwise not pregnant and not planning to become pregnant during the study follow-up period.
⁃ IC2. Subject has a documented fusiform infrarenal abdominal aortic aneurysm characterized by the following:
• Aneurysm size of 3.0-5.0 cm in maximum diameter for males; 3.0 - 4.5 for females (diameter measured in CTA perpendicular to the line of flow)
• Aortic neck diameter ≥17mm and ≤ 29mm
• Adequate landing zone for a tubular device of ≥ 30 mm length
⁃ IC3. Access vessel size and morphology allows endovascular access of 14F (or larger) introducer sheaths and catheters
⁃ IC4. Subject (or legal representative) understands the study requirements and the procedures and provided written informed consent.
⁃ IC5. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow-up visits.