About this trial
A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial 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.
Eligibility criteria
Qualifiers
Age ≥18 and ≤85 years old.
Symptoms of sudden focal or general neurological impairment.
There may be a causal relationship between vascular occlusion and nerve function defect.
Time from symptom onset to randomization ≤24h.
Disqualifiers
Pre stroke mRS>1 score.
There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
NIHSS≤6 points.
Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin < 10g /dl, platelet count < 100,000 /μl, uncorrected INR>1.5, PT> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).
Trial design
Treatments tested in this trial
- Mechanical thrombectomy
- 4°C saline infusion
- Normothermic saline infusion