Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection
Balt Extrusion
10,000 participants
Jul 12, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Provision of a signed, written and dated informed consent or non-opposition (where applicable)
Exclusion Criteria2
- 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.
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Interventions
Includes, but is not limited to, the following: * Access devices * Aneurysm treatment devices * Ischemic Stroke and peripheral occlusive diseases treatment devices * Arterio-Venous Malformations/fistulas treatment devices
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT04927156