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

NCT07330752 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Aneurysm, Abdominal Aortic

Interventions

DEVICE

A3-Shield Implantation

Implantation of the A3-Shield Device in the AAA Neck

Sponsors & Collaborators

  • Angiolutions GmbH

    lead INDUSTRY

Principal Investigators

  • Uwe Raaz, MD · Angiolutions GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2026-07-31
Completion
2028-07-31

Countries

  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330752 on ClinicalTrials.gov