Catheter-Based Focal Intracranial Hypothermia with Endovascular Reperfusion for Acute Large Artery Occlusive Stroke A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy in patients who have acute large artery occlusion in the anterior circulation of the brain. This multicenter, open-label, randomized controlled trial uses a blinded evaluation of outcomes to compare treatments. Participants are adults experiencing sudden neurological symptoms related to this type of stroke, and the study focuses on assessing recovery outcomes 90 days after the procedure. Participants are randomly assigned to one of two groups: one group receives mechanical thrombectomy combined with a cold 46C saline infusion (hypothermia group), while the other group receives mechanical thrombectomy with normal temperature saline infusion (normothermia group). The randomization accounts for age and stroke severity scores. The treatments involve catheter-based procedures to reopen blocked arteries and deliver the saline infusions. During the study, participants will be closely monitored with neurological assessments and imaging to confirm artery blockage and treatment effects. The main outcome measured is the proportion of patients achieving a favorable modified Rankin Score (0-2) at 90 days after treatment, indicating good functional recovery. Safety and effectiveness data will be collected throughout the study, and clinical follow-up is required to assess long-term outcomes and adverse events.

To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined with Endovascular Reperfusion Therapy for Patients with Acute Anterior Circulation Large Artery Occlusion