Clinical trial Recruiting at 10 sites Observational Ages 2 and up

Evaluating the safety and usability of BALT medical devices for various brain and vascular conditions

Official title: Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection

Run by Balt Extrusion · NCT04927156 · Data updated 2026-11-12

This study is testing how safe and effective BALT medical devices are for treating brain and blood vessel conditions like aneurysms and strokes.

More Acute Ischemic Stroke trials

Quick facts

Study typeObservational
Ages2 Years and up
SexAll
Enrollment10000 (estimated)
SponsorBalt Extrusion
Industry-sponsored
Locations12 sites (Angers and 11 other locations)
StatusRecruiting
StartedJuly 12, 2021
Main results expectedJune 2041
Study endsOctober 2041
Registry record updatedSeptember 18, 2025
Trial IDNCT04927156 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with conditions like intracranial aneurysms, brain arterial disease, or acute ischemic stroke who are treated with BALT medical devices.

Probably not a fit

Patients who have undergone multiple procedures involving BALT devices or have contraindications for their use may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect clinical data on the safety, performance, and usability of BALT medical devices used in treating conditions such as intracranial aneurysms and acute ischemic strokes. The study utilizes an electronic platform for post-marketing clinical follow-up, allowing for continuous data collection without a hierarchical order of objectives. Participants will provide informed consent to be part of this exploratory initiative, which focuses on real-world outcomes associated with the use of these devices.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of BALT medical devices' effectiveness and safety, leading to improved patient outcomes.

How similar studies have gone: While this approach is exploratory, similar post-marketing follow-up studies have shown success in gathering valuable data on medical devices.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Provision of a signed, written and dated informed consent or non-opposition (where applicable)

Exclusion Criteria

* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)
* Contra-indications of each device as described in the instructions for use.

Where it's running

  • CHU Angers
    Angers, France
    Recruiting
  • Chu Bordeaux
    Bordeaux, France
    Recruiting
  • CHU Grenoble Alpes
    La Tronche, France
    Recruiting
  • Hôpital Roger Salengro
    Lille, France
    Recruiting
  • Kremlin Bicêtre - APHP
    Paris, France
    Recruiting
  • Chu Tours
    Tours, France
    Recruiting
Show 6 more locations
  • Halle
    Halle, Germany
    Recruiting
  • Hospital: Fundacion Jimenez Diaz
    Madrid, Spain
    Recruiting
  • Unversitario Central de Asturias
    Oviedo, Spain
    Recruiting
  • Hospital Universitario Marqués de Valdecilla (HUMV)
    Santander, Spain
    Recruiting
  • Hospital Clinico Universitario San Carlos
    Madrid, Spain
    Terminated
  • Hospital Universitario Miguel Servet
    Zaragoza, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.