Evaluating the safety and usability of BALT medical devices for various brain and vascular conditions
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Balt Extrusion Industry-sponsored |
| Locations | 12 sites (Angers and 11 other locations) |
| Trial ID | NCT04927156 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have undergone multiple procedures involving BALT devices or have contraindications for their use may not benefit from this study.
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 performed: While this approach is exploratory, similar post-marketing follow-up studies have shown success in gathering valuable data on medical devices.
Eligibility criteria
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 this trial is running
Angers and 11 other locations
- 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)
- Halle — Halle, Germany (Recruiting)
- Hospital: Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
- Hospital Clinico Universitario San Carlos — Madrid, Spain (Terminated)
- Unversitario Central de Asturias — Oviedo, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla (HUMV) — Santander, Spain (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.