About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- intra-arterial local therapeutic hypothermia
- Control (Normal saline)