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

NCT07514949 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Stroke
  • Acute Ischemic Stroke
  • Blood-Brain Barrier

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

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
2026-04-15
Primary Completion
2026-11-15
Completion
2026-11-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07514949 on ClinicalTrials.gov