Not Yet RecruitingNot Applicable

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

China6 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;
✓. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \<620×10-6mm2/s lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \<30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.

Exclusion criteria

✕. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;
✕. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\>70%);
✕. Or imaging suggests that the area of cerebral infarction is involved bilaterally;
✕. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.

What they're measuring

Failed of drilling

Timeframe: during 3 days of treatment

Number of drug-leakage events

Timeframe: during 3 days of treatment

Patients' tolerance of therapy

Timeframe: during 3 days of treatment

Failed for other reasons

Timeframe: during 3 days of treatment

Rate of participants with infection events

Timeframe: within 90±7 days after randomization

Rate of intracranial hemorrhage

Timeframe: within 90±7 days after randomization

Rate of bleeding

Timeframe: within 90±7 days after randomization

Rate of hepatic insufficiency

Timeframe: within 90±7 days after randomization

Trial details

NCT IDNCT07514949

Sponsoryilong Wang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-15

Contact for this trial

Yilong Wang, PhD+MD

18842627325 yilong528@gmail.com

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;
✓. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \<620×10-6mm2/s lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \<30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.

Exclusion criteria

✕. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;
✕. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\>70%);
✕. Or imaging suggests that the area of cerebral infarction is involved bilaterally;
✕. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.

What they're measuring

Failed of drilling

Timeframe: during 3 days of treatment

Number of drug-leakage events

Timeframe: during 3 days of treatment

Patients' tolerance of therapy

Timeframe: during 3 days of treatment

Failed for other reasons

Timeframe: during 3 days of treatment

Rate of participants with infection events

Timeframe: within 90±7 days after randomization

Rate of intracranial hemorrhage

Timeframe: within 90±7 days after randomization

Rate of bleeding

Timeframe: within 90±7 days after randomization

Rate of hepatic insufficiency

Timeframe: within 90±7 days after randomization