Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07330752

PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective "A3- Shield" System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase

Led by Angiolutions GmbH · Updated on 2026-01-09

12

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of the A3-Shield implant in adults with small, asymptomatic infrarenal abdominal aortic aneurysms. This trial addresses the lack of treatments that prevent the growth of small abdominal aortic aneurysms, which often enlarge over time and may require risky surgical repair. The study focuses on whether the A3-Shield device can mechanically stabilize the aneurysm neck and reduce harmful pulse wave forces that contribute to aneurysm enlargement. Participants receive a catheter-based implantation of the A3-Shield device guided by fluoroscopy. After the procedure, they attend scheduled follow-up visits which include clinical exams and imaging tests like ultrasound and computed tomography. This trial does not include randomization or a control group and aims to gather early data on the device's performance and safety. During the study, participants will undergo assessments of safety outcomes including major adverse events within 30 days and longer-term safety up to 24 months. Effectiveness measures such as successful aneurysm treatment, aneurysm size stability or shrinkage, and immobilization of the aneurysm neck are evaluated at multiple time points. Participants must be able to return for follow-up visits, and the total study duration includes assessments up to two years after implantation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 follow-up
  • Documented fusiform infrarenal abdominal aortic aneurysm with size 3.0-5.0 cm for males or 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 suitable for endovascular access with 14F or larger introducer sheaths
  • Ability to understand study requirements and provide informed consent
  • Agreement and ability to return for all scheduled follow-up visits
Not Eligible

You will not qualify if you...

  • Aneurysms that are 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 at the attachment site (>25% vessel circumference)
  • Arterial access not suitable for device delivery systems
  • Acute myocardial infarction within 180 days before procedure
  • Untreated coronary artery disease requiring revascularization
  • Congestive heart failure (NYHA class III or IV) or severe valve 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), low platelet count (<50,000/mm3) or high white blood cell count (>700,000/mm3)
  • Major unrelated surgery planned within 30 days before or after device implantation
  • Known allergies to contrast agents or device components not manageable by pre-medication
  • Participation in another investigational study without completed follow-up within 30 days
  • Morbid obesity (BMI ≥40 kg/m2) or conditions preventing adequate aortic imaging
  • Active infection or chronic systemic illness interfering with study
  • Current substance abuse problems (smoking allowed)
  • Severe dementia
  • Life expectancy under 24 months due to other health conditions based on investigator assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of the procedure

Participants undergo catheter-based implantation of the A3-Shield device in the abdominal aortic aneurysm neck under fluoroscopic guidance.

1 visit (in-person)

Follow-up

Duration - Up to 24 months post implantation

Participants attend scheduled follow-up visits including clinical examinations and imaging such as ultrasound and computed tomography to assess safety and effectiveness of the device.

Multiple visits at 30 days, 6 months, 12 months, and 24 months post implantation

Trial Site Locations

Total: 1 location

1

Еzgu Niyат Llc

Tashkent, Uzbekistan, 100027

Actively Recruiting

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Research Team

U

Uwe Raaz, MD

I

Isabel N Schellinger, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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