First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
ConditionAneurysm, Abdominal Aortic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAngiolutions GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
symptomatic
ruptured
thoracic
suprarenal
Trial design
Design model
Single group
Treatments tested in this trial
A3-Shield Implantation
DeviceImplantation of the A3-Shield Device in the AAA Neck
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Device implantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 30 days of the index procedure2
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
Time frame
Conclusion of the index procedureSecondary outcomes
1
Secondary safety endpoint: Absence of Major Adverse Events
Absence of Major Adverse Events (MAEs)
Time frame
180 days, 12 months,vand 24 months post index procedure.2
Secondary safety endpoint: Procedure related complications
Procedure related complications
Time frame
30 days, 6 months, 12 months, and 24 months post index procedure3
Secondary safety endpoint: Device related complications
Device related complications. Device related complications are defined as device fracture(s), device migration, and device occlusion requiring intervention.
Time frame
30 days, 6 months, 12 months, and 24 months post index procedure4
Secondary effectiveness endpoint: Freedom of aneurysmal sac enlargement
Freedom of aneurysmal sac enlargement. Enlargement is defined as a maximum diameter increase of \> 5 mm per year, or aneurysm sac volume increase of \> 10% per year, as assessed by CT scans and an independent core laboratory
Time frame
Day 30, 12 months, and 24 months post index procedureOther outcomes
1
Quality of Life (QoL)
Short Form-36 (SF-36) Health Survey will be used to assess quality of life. The scale ranges from 0 to 100, where higher scores represent better quality of life. Subscale scores (each 0-100, higher is better) will also be reported.
Time frame
6 months, 12 months, 4 monthsSponsors and contacts
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Source ClinicalTrials.gov