Not Yet RecruitingNot Applicable

Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction

322 participantsStarted 2026-05-01

Plain-language summary

A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for acute patients with a Large Core Infarction.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years old.
✓. The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
✓. Time from symptom onset to randomization ≤24h.
✓. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up.
✓. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
✓. NCCT ASPECTS value of 3 to 5 based on findings from non-contrast CT within 24 hours after stroke onset (defined as the time the patient was last known to be well), with no limitation with respect to infarct-core volume;
✓. NCCT ASPECTS value of 0 to 2 based on findings from non-contrast CT within 24 hours after stroke onset and an infarct-core volume between 70 ml and 100 ml;
✓. NCCT ASPECTS value greater than 5 based on findings from non-contrast CT after stroke onset and an infarct-core volume of 70 to 100 ml.

Exclusion criteria

✕. Pre stroke mRS\>1 score.
✕. Multivessel Occlusion
✕. Concomitant untreated intracranial aneurysms, intracranial tumors (with the exception of small meningiomas), or intracranial vascular malformations.
✕. History of intracranial hemorrhage within 6 months, including parenchymal hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
✕. History of gastrointestinal hemorrhage, genitourinary bleeding, acute myocardial infarction (AMI), cranial trauma, or having undergone major surgical procedures within the past month.
✕. The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (platelet count \< 40,000 /μl, uncorrected INR\>2.0).
✕. Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians.
✕. Severe heart, liver, kidney disease.

What they're measuring

Proportion of patients with modified Rankin Score 0-2 at 90 days.

Timeframe: 90±7 days after randomization

Trial details

NCT IDNCT07232082

SponsorFirst Affiliated Hospital of Wannan Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Zhiming Zhou, PhD

(++)86-(+)-553-5739543 neuro_depar@hotmail.com

View on ClinicalTrials.gov More Stroke trials