Clinical Trial

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

Study acronym: SOLUTION-2
Recruiting
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Record status
This record was last updated January 28, 2025 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-16; most recent amendment 2025-01-24.
Status change: Not Yet Recruiting → Recruiting 2024-04-25
Trial Details
NCT Number NCT06374667
Lead Sponsor yilong Wang
Conditions Stroke, Acute Ischemic, Blood-Brain Barrier
Enrollment 134 participants
Start Date 2024-04-22
Primary Completion 2026-03-15 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-01-28