FOCUS-Cool
(2026)Objective
To test whether selective intra-arterial cold saline (SCI) hypothermia as an adjunct to EVT improves 90-day functional outcome in anterior circulation large-vessel occlusion stroke.
Study Summary
• Primary 90-day mRS shift: NS.
• 90d mRS 0-2: 50.8% vs 46.9% (NS); sICH 3.1% vs 6.2% (NS).
• Any ICH: 26.9% vs 45.3% (P=0.002).
• Ipsi-tympanic temp drop ~1.05 degC documented.
• 90d mRS 0-2: 50.8% vs 46.9% (NS); sICH 3.1% vs 6.2% (NS).
• Any ICH: 26.9% vs 45.3% (P=0.002).
• Ipsi-tympanic temp drop ~1.05 degC documented.
Intervention
IA selective cold saline (4 degC) + EVT vs EVT alone
Inclusion Criteria
China, multicenter. ICA-IC or M1 occlusion, NIHSS 6-25, EVT within 24 h (<=6 h with ASPECTS >=6; 6-24 h with perfusion mismatch).
Study Design
Arms: IA-SCI cold saline + EVT vs EVT alone
Patients per Arm: SCI n=130 vs Control n=128 (total 258)
Outcome
• Primary 90-day mRS shift: NS.
• 90d mRS 0-2: 50.8% vs 46.9% (NS).
• sICH: 3.1% vs 6.2% (NS).
• Any ICH: 26.9% vs 45.3% (P=0.002).
• Significant ipsi-tympanic temperature drop of 1.05 degC.
• 90d mRS 0-2: 50.8% vs 46.9% (NS).
• sICH: 3.1% vs 6.2% (NS).
• Any ICH: 26.9% vs 45.3% (P=0.002).
• Significant ipsi-tympanic temperature drop of 1.05 degC.