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NOT YET RECRUITING
NCT07514949
NA

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

Sponsor: yilong Wang

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-04-15

Completion Date

2026-11-15

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DEVICE

RK-4 ICO injection

Patients included will be given skull outer plate drilling surgery and RK-4 ICO injection under local anesthesia and sedation using the intracalvariosseous injection device. The drilling and injection will be conducted once a day for 3 consecutive days.

OTHER

Conventional treatment

standard treatment and management according to related guidelines

Locations (1)

Beijing Tiantan Hospital

Beijing, China