Ongoing Safety and Effectiveness Registry for Medtronic Neurovascular Devices Used in Treatment of Intracranial Aneurysms and Acute Ischemic Stroke

What this Trial Is About

This observational, prospective, multi-center registry studies patients treated with Medtronic Neurovascular devices for intracranial aneurysms and acute ischemic stroke. It aims to continuously evaluate and report the safety and effectiveness of these market-approved products in real-world clinical practice. The registry includes patients who receive treatment using specific Medtronic devices under conditions MDT16056 and MDT17077. Participants undergo treatment with Medtronic devices designed either for embolization of intracranial aneurysms or for revascularization of blood vessels affected by acute ischemic stroke. The study involves a single-arm design without randomization, monitoring patients receiving standard device treatments as part of routine care. Data are collected during and after treatment to assess outcomes over time. During the study, participants will be followed up to assess clinical success, defined as complete occlusion of the aneurysm without retreatment or significant artery narrowing at one year, and functional independence measured by the modified Rankin Scale score at 90 days. The registry also collects safety and effectiveness data through periodic reporting. Participation may last up to several years, with follow-up visits scheduled according to the standard care and registry protocol to track outcomes and adverse events.

Neurovascular Product Surveillance Registry