The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction

Summary

A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.

Timeline

Start

2024-04-22

Primary completion

2026-03-15

Completion

2027-03-15

Publications

• Wang N, Zhang M, Yang M, Liu W, Liu W, Ou Y, Zhou M, Wang X, Sun Z, Pan Y, Wang Y, Wang Y. Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial. Stroke Vasc Neurol. 2026 Mar 4;11(1):130-135. doi: 10.1136/svn-2024-004011.

Drugs

Indications