Actively Recruiting
First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
Led by Angiolutions GmbH · Updated on 2026-01-09
12
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects 18 years or older at screening
- Female subjects must be of non-childbearing potential or not pregnant and not planning pregnancy during the study
- Documented fusiform infrarenal abdominal aortic aneurysm: 3.0-5.0 cm in diameter for males; 3.0-4.5 cm for females
- Aortic neck diameter between 17 mm and 29 mm
- Adequate landing zone for a tubular device of at least 30 mm length
- Access vessel size and shape allow use of 14F or larger introducer sheaths and catheters
- Ability to understand study requirements and provide written informed consent
- Willingness and ability to return for all scheduled follow-up visits at the study hospital
You will not qualify if you...
- Aneurysm that is symptomatic, ruptured, thoracic, suprarenal, thoraco-abdominal, isolated ilio-femoral, mycotic, inflammatory, pseudoaneurysmatic, or traumatic
- Any type of aortic dissection
- Congenital connective tissue diseases such as Marfan's or Ehlers-Danlos Syndrome
- Significant aortic mural thrombus (>25% of vessel circumference) at the device attachment site
- Arterial access unsuitable for device delivery as per device instructions
- Acute myocardial infarction within 180 days before the procedure
- Untreated coronary artery disease requiring revascularization
- Congestive heart failure (NYHA class III or IV) or severe valvular disease
- Stroke or transient ischemic attack within 90 days before enrollment
- End-stage renal disease, creatinine > 2.0 mg/dl, or dialysis
- History of bleeding disorders or coagulopathy
- Low hemoglobin (<9 g/dL), abnormal platelet or white blood cell counts
- Planned or recent major surgery or intervention within 30 days of device implantation
- Known hypersensitivity to contrast agents or device components
- Participation in another investigational study with incomplete follow-up within 30 days before consent
- Morbid obesity (BMI ≥ 40 kg/m2) or conditions preventing clear aortic imaging
- Active infection or chronic systemic illness at procedure time
- Current substance abuse problems (smoking allowed)
- Severe incapacitating dementia
- Life expectancy under 24 months due to other medical conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Еzgu Niyат Llc
Tashkent, Uzbekistan, 100027
Actively Recruiting
Research Team
U
Uwe Raaz, MD
CONTACT
I
Isabel N Schellinger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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