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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Balt Extrusion Industry-sponsored |
| Locations | 12 sites (Angers and 11 other locations) |
| Status | Recruiting |
| Started | July 12, 2021 |
| Main results expected | June 2041 |
| Study ends | October 2041 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT04927156 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
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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
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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
- Study coordinator: Clinical Affairs Department
- Email: Evidence@baltgroup.com
- Phone: +33 1 39 89 46 41
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.