PRINCIPIIS-FIH
PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective "A3- Shield" System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase
Sponsor study identifier
interventional
12
1 country
1
Study Start
November 28, 2025
Actual (reported)Primary Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2025
Actual (reported)November 28, 2025
Actual (reported)January 9, 2026
Actual (reported)July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 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
Quality of Life (QoL)
6 months, 12 months, 4 months
A3-Shield Implantation
Implantation of the A3-Shield Device in the AAA Neck
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Еzgu Niyат Llc
Tashkent, 100027, Uzbekistan
Uwe Raaz, MD
Angiolutions GmbH
First Submitted
November 28, 2025
First Posted
January 9, 2026
Study Start
November 28, 2025
Actual (reported)Primary Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
Contact the study team to confirm eligibility.
Study Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 9, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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