Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
Recruiting
Observational Study
Intracranial Aneurysm
Brain Arterial Disease
Acute Ischemic Stroke
Peripheral Vascular Diseases
AVM - Cerebral Arteriovenous Malformation
AVM
Fistulas Arteriovenous
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 2 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 10,000 (estimated)
- Sponsor
- Balt Extrusion · Industry
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About This Trial
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices. This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.
Trial Locations
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Eligibility 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 ins…
Contacts