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

NCT07330752 | Recruiting

• 1 other identifier: AL-P001-2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

A3-Shield; Small AAA; Pulse Wave Modulation

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint: Absence of Major Adverse Events

  Absence of Major Adverse Events (MAEs). MAE is defined as a composite of death, stroke, myocardial infarction, new onset renal failure (requiring dialysis), respiratory failure (requiring mechanical ventilation), paralysis or paraparesis, bowel ischemia requiring surgical intervention or procedural blood loss ≥ 1,000 cc.

  Within 30 days of the index procedure

• Primary effectiveness endpoint: Successful aneurysm treatment

  Successful aneurysm treatment defined as the composite of 1. Technical success, defined as successful insertion of the delivery system through the vasculature, successful deployment of the device at the intended location, and successful removal of the delivery system 2. Immobilization of the distal AAA neck, defined as aortic circumferential cyclic strain \< 10% as measured via vascular ultrasound at the conclusion of the index procedure and assessed by an independent core laboratory

  Conclusion of the index procedure

Secondary Outcomes (9)

• Secondary safety endpoint: Absence of Major Adverse Events

  180 days, 12 months,vand 24 months post index procedure.

• Secondary safety endpoint: Procedure related complications

  30 days, 6 months, 12 months, and 24 months post index procedure

• Secondary safety endpoint: Device related complications

  30 days, 6 months, 12 months, and 24 months post index procedure

• Secondary effectiveness endpoint: Freedom of aneurysmal sac enlargement

  Day 30, 12 months, and 24 months post index procedure

• Secondary effectiveness endpoint: Aneurysmal sac shrinkage

  Day 30, 12 months, and 24 months post index procedure

Other Outcomes (1)

• Quality of Life (QoL)

  6 months, 12 months, 4 months

Study Arms (1)

Device implantation

EXPERIMENTAL

A3-Shield Implantation

Device: A3-Shield Implantation

Interventions

A3-Shield Implantation DEVICE

Implantation of the A3-Shield Device in the AAA Neck

Device implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• EC1. Subject has an aneurysm that is:
• symptomatic
• ruptured
• thoracic
• suprarenal
• thoraco-abdominal
• isolated ilio-femoral
• mycotic
• inflammatory
• pseudoaneurysmatic
• traumatic
• EC2. Subject has any type of aortic dissection.
• EC3. Subject has congenital connective tissue disease, e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome.
• EC4. Subject has significant (\>25% of vessel circumference of aortic neck) aortic mural thrombus at the attachment site that could compromise fixation of the device.
• EC5. Subject has arterial access that is not acceptable for the device delivery systems as defined in the device Instructions For Use.

Sponsors & Collaborators

• Angiolutions GmbH: lead

Study Sites (1)

Еzgu Niyат Llc

Tashkent, 100027, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Uwe Raaz, MD

  Angiolutions GmbH

  STUDY DIRECTOR

Central Study Contacts

Uwe Raaz, MD

CONTACT

‭+49 (0) 511 9666938‬; uwe@angiolutions.com

Isabel N Schellinger, MD

CONTACT

‭+49 (0) 511 9666938‬; isabel@angiolutions.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 9, 2026
• Study Start: November 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)