Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases, AVM - Cerebral Arteriovenous Malformation, AVM

Intervention / Treatment
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* Device: BALT medical devices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BALT medical devices<br> | Device: BALT medical devices<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of device-specific safety indicator(s). | Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families. | From the procedure to 12 months post-procedure depending on the device family. | 
| Rate of devices achieving its intended use. | Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families. | From the procedure to 12 months post-procedure depending on the device family. | 
| Rate of devices achieving its specific performance indicator(s). | Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families. | From the procedure to 12 months post-procedure depending on the device family. | 
| Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator | Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families. | From the procedure to 12 months post-procedure depending on the device family. |