Abstract Background and aims The cerebroprotective effects of hypothermia via selective intra-arterial cooling infusion (SI-AC) as an adjunct to endovascular thrombectomy (EVT) for acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) are uncertain. Methods We conducted a multicenter, randomized, controlled, and sigle blinded clinical trial conducted at 12 hospitals in China. Patients with anterior circulation LVO-AIS presenting within 24 hours of symptom onset were randomized 1:1 to receive SI-AC plus EVT (SI-AC group) or EVT (control group). The primary outcome was mRS score distribution at 90 days. Results A total of 258 patients were randomized (130 to the SI-AC group and 128 to the control group) . There was no significant difference between the groups in the distribution of mRS scores at 90 days (unadjusted common odds ratio, 1.15; 95% CI, 0.75 to 1.77). Secondary outcomes showed no significant differences in mRS (0-2), mRS (0-1), or early neurologic improvement. For safety outcomes, SI-AC was associated with a significantly lower incidence of intracranial hemorrhage at 24 hours compared to the control group (unadjusted risk ratio, 0.64; 95% CI, 0.43 to 0.95). There was no significant difference in symptomatic intracranial hemorrhage rates (unadjusted risk ratio, 0.82; 95% CI, 0.26 to 2.62) or 90-day mortality (unadjusted risk ratio, 0.93; 95% CI, 0.49 to 1.75). Conclusions SI-AC did not improve functional recovery at 90 days compared to EVT alone, but it reduced the incidence of intracranial hemorrhage. Further research is needed to better understand its role in improving clinical outcomes in AIS patients undergoing EVT. Trial registration: ClinicalTrials.gov (NCT06485427). Conflict of interest Figure 1 - belongs to Conclusions
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