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

NCT06374667 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

  • Stroke, Acute Ischemic
  • Blood-Brain Barrier

Interventions

PROCEDURE

Y-3 ICO injection

Patients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days.

DRUG

Y-3 intravenous injection

Patients included will be given Y-3 intravenous injection for 7 consecutive days.

OTHER

Conventional treatment

standard treatment and management according to related guidelines during the entire treatment period

Sponsors & Collaborators

  • yilong Wang

    lead OTHER

Principal Investigators

  • Yilong Wang, PhD，MD · Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2026-03-15
Completion
2027-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374667 on ClinicalTrials.gov