The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction(SOLUTION-2).

This document provides information about a clinical trial, NCT06374667, that is investigating the efficacy and safety of Y-3 intracalvariosseous (ICO) injection compared to intravenous injection in patients with acute large hemispheric infarction (LHI) who have contraindications or poor outcomes from reperfusion therapy. A pilot study showed that ICO injection of Y-3 improved 90-day functional scores in patients with malignant middle cerebral artery infarction. The trial aims to further explore the potential benefits of ICO injection in improving outcomes for LHI patients. The study will assess primary outcomes such as favorable clinical outcome and secondary outcomes including infarct volume, neurofunctional deficit, and depression scale scores. The trial is currently in the recruitment phase and is expected to be completed by March 2026. The eligibility criteria for participants are also outlined in the document. [Extracted from the article]