REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.
• Patient is ≥ 21 and ≤ 85 years of age.
• Patient has a pre-morbid mRS ≤ 1.
• Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
• Patient has an NIHSS score ≥ 5 at time of intervention.
• Symptom onset is within 8 hours of when groin puncture can be achieved.
• Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient will be treated using the direct aspiration as first line treatment technique and the decision to use this technique and the study device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent.
• Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.
• Neuroimaging (CT/CTA and/or MR/MRA) demonstrates intracranial vessel occlusion.
• Symptom onset is within 24 hours of when arterial access puncture can be achieved.
• Patient will be treated using an FDA-cleared/approved and market-released MicroVention mechanical thrombectomy device as the initial, primary treatment device and the decision to use this device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Note: For the purposes of this protocol, ancillary/accessory devices such as balloon guide catheters and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent within 48 hours of procedure.