RESCUE: A Randomized, Blinded, Placebo-controlled, Parallel Group Design to Determine the Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy
A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.
• Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
• Age 18 years or older.
• Onset (last-known-well) time to randomization time within 24 hours.
• Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
‣ NIHSS \> 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
⁃ NIHSS \> 10 for M2-MCA occlusion.
• Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.
• Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤2. Patient must be living without requiring nursing care.
• Qualifying imaging performed less than 2 hours prior to randomization.
• Consent process completed as per applicable laws and regulation and the IRB requirements.