Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With Endovascular Thrombectomy in Acute Ischemic Stroke

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adding selective intra-arterial cooling infusion to endovascular therapy in treating acute ischemic stroke caused by large vessel blockage in the brain's anterior circulation. This multicenter, randomized, controlled, and double-blinded clinical trial aims to improve outcomes beyond what current best medical management and endovascular therapy achieve, by targeting the affected brain tissue with mild cooling to reduce injury without lowering the body's core temperature significantly. Participants are divided into two groups: one receives standard best medical management and endovascular therapy, while the other group also receives selective intra-arterial cold saline infusion before and after recanalization to cool the ischemic brain region. The cooling infusion involves delivering cold saline through a micro-catheter at specific rates before and after revascularization. The study includes multiple assessments over time, including face-to-face and telephone interviews at various intervals up to 90 days after treatment. During the study, participants are closely monitored through neurological exams, imaging, and temperature measurements. Researchers assess stroke outcomes using the Modified Rankin Scale primarily at 90 days, along with other functional and neurological scores, infarction volume, brain activity via EEG, and safety outcomes such as hemorrhage and infections. The trial also tracks adverse events and survival, with interviews conducted at baseline, 24 and 48 hours, 7 days or discharge, 30 days, and 90 days following randomization to evaluate recovery and safety.

Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke