A3-Shield system to stabilize small abdominal aortic aneurysms

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

This study will try the A3-Shield implant in adults with small, asymptomatic infrarenal abdominal aortic aneurysms to see if it can mechanically stabilize the aneurysm neck and be safely implanted.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Angiolutions GmbH (industry)
• Locations: 1 site (Tashkent)
• Trial ID: NCT07330752 on ClinicalTrials.gov

What this trial studies

This first-in-human, non-randomized feasibility study implants the A3-Shield device via a catheter-based approach in adults with small infrarenal abdominal aortic aneurysms. The primary focus is technical feasibility of implantation and whether the device produces mechanical immobilization of the aneurysm neck. Participants undergo peri-procedural safety monitoring and scheduled follow-up visits with imaging (ultrasound and CT) and clinical assessments. There is no randomized control group, and outcomes will inform safety and future development.

Who should consider this trial

Good fit: Adults (≥18 years) with small, asymptomatic fusiform infrarenal AAAs within the study size limits, suitable aortic neck anatomy and vascular access for a 14F introducer, and who can attend the Tashkent study center for follow-up are ideal candidates.

Not a fit: Patients with large or symptomatic AAAs, unsuitable aortic neck or access vessel anatomy, inability to undergo catheter-based procedures, or who are pregnant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the implant could stabilize small aneurysms, potentially slowing or halting growth and reducing the need for later surgical repair.

How similar studies have performed: This is a first-in-human trial of a novel biomechanical implant; there are no established human studies showing success with this specific approach, though endovascular repair techniques have limited applicability for small AAAs.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

EC6. Subject has had an acute myocardial infarction within 180 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).

EC7. Subject has untreated coronary artery disease, which in the opinion of the treating physician, is clinically significant and requires revascularization.

EC8. Subject has congestive heart failure (NYHA class III or IV) or high-grade valvular disease.

EC9. Subject has had a cerebrovascular accident or transient ischemic attack within the past 90 days prior to study enrollment.

EC10. Subject has end-stage renal disease or has a creatinine \> 2.0 mg/dl or is on dialysis.

EC11. Subject has a history of bleeding diathesis or coagulopathy.

EC12. Subject has Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.

EC13. Subject has had or plans to have an unrelated major surgical or interventional procedure (including trans-aortic interventions) within 30 days prior or post implantation of the device.

EC14. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to the device components.

EC15. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the informed consent form in this study.

EC16. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented conditions that inhibit radiographic visualization of the aorta.

EC17. Subject has an active infection or chronic systemic illness at the time of the index procedure that may interfere with study objectives.

EC18. Subject has current problems with substance abuse.Smoking is NOT an exclusion criterion.

EC19. Subject has severe incapacitating dementia.

EC20. Subject has a life expectancy of less than 24 months due to comorbid conditions based on the assessment of the investigator at the time of enrollment.

Where this trial is running

Tashkent

• Еzgu Niyат Llc — Tashkent, Uzbekistan (RECRUITING)

Study contacts

• Study coordinator: Uwe Raaz, MD

Conditions: Aneurysm, Abdominal Aortic, A3-Shield, Small AAA, Pulse Wave Modulation