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

What this Trial Is About

Researchers are collecting clinical data on BALT medical devices through an electronic platform designed for post-marketing follow-up. This study is exploratory and aims to gather information on the safety, performance, and usability of these devices without a set hierarchy of objectives or outcomes. The focus is on devices used for various vascular conditions such as intracranial aneurysm, brain arterial disease, acute ischemic stroke, peripheral vascular diseases, cerebral arteriovenous malformations, and arteriovenous fistulas. The devices being studied include access devices, aneurysm treatment devices, ischemic stroke and peripheral occlusive disease treatment devices, and arterio-venous malformations or fistulas treatment devices. Data collection includes both prospective and retrospective clinical information from multiple international centers. The platform monitors these devices from the time of the procedure up to 12 months afterward, depending on the device family. Participants are involved through data collection related to the use of these devices. Researchers measure the rate of device-specific safety indicators, the rate at which devices achieve their intended use and specific performance indicators, and device usability based on a Likert-type scale. The study spans an extended period, allowing ongoing monitoring of device outcomes during the post-procedure year.

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