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RECRUITING
NCT06374667
NA

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

Sponsor: yilong Wang

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2024-04-22

Completion Date

2027-03-15

Last Updated

2025-01-28

Healthy Volunteers

No

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

Locations (6)

The first affiliated hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

North China University of Science and Technology Affiliated Hospital

Tangshan, Heibei, China

Tangshan Municipal Worker's Hospital

Tangshan, Heibei, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Tianjin Huanhu hospital

Tianjin, China