Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke (SLEDAIS)

Inclusion criteria

• Aged 18 to 80 years (inclusive).
• Time from last known normal to arrival at the first hospital is within 6 hours.
• Clinical and imaging diagnosis of acute ischemic stroke, with a Los Angeles Motor Scale (LAMS) score ≥ 4, or occlusion of the internal carotid artery, M1/M2 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery confirmed by CTA/MRA at the first or target hospital.
• ASPECTS score ≥ 6 on non-contrast head CT at the first hospital.
• Clinically assessed as planned for immediate transfer to a target hospital for evaluation of endovascular therapy (final decision on whether to perform EVT is made by the neuro-interventionist at the target hospital based on imaging and clinical status).
• Written informed consent signed by the patient or their legal representative.

Exclusion criteria

• Allergy to contrast agents, nickel, titanium, or their alloys.
• Known allergy to dexborneol, edaravone, or excipients.
• Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
• Patients receiving intravenous thrombolysis alone.
• Severe impairment of consciousness (e.g., GCS score < 8) or inability to cooperate with sublingual administration.
• Severe hepatic or renal insufficiency (e.g., ALT/AST > 3 times the upper limit of normal, Cr > 2 times the upper limit of normal).
• Estimated inter-hospital transfer time > 3 hours.
• Pregnant or lactating women.
• Arterial tortuosity and/or other arterial diseases where the thrombectomy device is expected to be unable to reach the target vessel.
• Brain tumors with mass effect on imaging (except small meningiomas).
• Currently participating in other drug clinical trials.
• History of neurological or psychiatric diseases that hinder the assessment of neurological function.
• Any late-stage disease with an expected life expectancy < 6 months.