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

This trial aims to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute patients with a Large Core Infarction. Participants were centrally randomized in a 1:1 ratio to either endovascular thrombectomy (EVT) combined with intra-arterial cold saline infusion (IA-CSI) (hypothermia group) or EVT combined with normothermic saline infusion (normothermia group).

Inclusion criteria

General 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.

Specific Neuroimaging Inclusion Criteria

• 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.
• Known allergy to contrast media or related medications.
• Refractory hypertension uncontrolled by medication (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
• glucose <2.8 mmol/L or >22.2 mmol/L；
• Pregnancy or lactation；
• the expected survival time is less than 12 months.
• Participating in other clinical trials, in the investigational phase or in the follow-up phase.
• Other conditions deemed by investigators to pose significant risks or render participation unsuitable (e.g. inability to comply due to psychiatric/cognitive/emotional disorders).