Related Experiment Video
Updated: Mar 13, 2026
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Catheter-Based Focal Hypothermia With Endovascular Reperfusion in Acute Anterior Circulation Large Artery Occlusion
Wen Sun1, Xuelin Zhang1, Miaomiao Hu1
1Department of Neurology, Centre for Leading Medicine and Advanced Technologies of IHM, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui (W.S., X.Z., M.H., Y.L.).
Background:
Large vessel occlusion accounts for 28% to 46% of acute ischemic strokes, with mechanical thrombectomy (MT) demonstrating established efficacy. However, functional independence rates remain suboptimal, necessitating adjuvant neuroprotective strategies. Therapeutic hypothermia represents the most promising intervention among evaluated neuroprotective approaches. Our previous multicenter pilot trial indicated that catheter-based focal intracranial hypothermia exhibits a favorable safety profile and may confer prognostic benefits. However, this preliminary finding mandates rigorous validation. This trial aims to evaluate the efficacy and safety of catheter-based focal intracranial hypothermia combined with MT in patients with acute anterior circulation large artery occlusion.
Methods:
The CHILL-ART (Catheter-Based Focal Intracranial Hypothermia Combined With Endovascular Reperfusion Therapy for Patients With Acute Anterior Circulation Large Artery Occlusion) is an investigator-initiated, multicenter, PROBE (Prospective Randomized Open-label Blinded End Point) trial. Twenty-six comprehensive stroke centers across China will enroll 262 eligible patients with occlusion of the internal carotid artery and the M1 segment of the middle cerebral artery within 24 hours of onset. Participants will be randomized 1:1 to receive either MT plus 350 mL of 4 °C saline (hypothermia group) or MT plus 350 mL of room-temperature (22-25 °C) saline (control group).
Results:
The primary outcome is the proportion of patients achieving a modified Rankin Scale score of 0 to 2 at 90 days. Secondary outcomes include excellent outcome (modified Rankin Scale score, 0-1), ordinal modified Rankin Scale shift analysis, reperfusion success rate (modified Thrombolysis in Cerebral Infarction [mTICI] score, 2b-3), infarct volume at 72 hours to 7 days, recurrent occlusion rate, rectal temperature, and early neurological deterioration. Safety end points comprise symptomatic intracranial hemorrhage within 72 hours, any intracranial hemorrhage, pneumonia, and urinary tract infections, cerebral herniation, coagulation disorders, bradycardia, electrolyte disturbances, vasospasm, deep vein thrombosis, and 90-day mortality.
Conclusions:
The CHILL-ART trial will provide evidence of the efficacy and safety of catheter-based focal intracranial hypothermia as adjuvant therapy combined with MT for patients with acute anterior circulation large artery occlusion.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT06758609.
