Clinical Trial

The Feasibility and Safety of RK-4 Injection Bypassing Blood-brain Barrier in the Treatment of Acute Large Hemispheric Infarction Using Intracalvariosseous Injection Device

Study acronym: SOLUTION-ICD
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
A pilot study confirmed the feasibility and safety of neuroprotectant RK-4 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 investigate the feasibility and safety of neuroprotective agent RK-4 injection using intracalvariosseous injection device in patients with acute large hemispheric infarction (LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
Trial Details
NCT Number NCT07514949
Lead Sponsor yilong Wang
Conditions Stroke, Acute Ischemic Stroke, Blood-Brain Barrier
Enrollment 6 participants
Start Date 2026-04-15
Primary Completion 2026-11-15 (estimated)
Study Completion 2026-11-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-07