Reperfusion With Hypothermia in Acute Ischemic Stroke (RESCUE-HYPO)
Ischemic Stroke, Revascularization, Endovascular Treatment
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
Eligibility Criteria
Inclusion Criteria: Aged 18-80 years; Patients with symptoms consistent with an AIS; Pre-stroke mRS score 0-1; NIHSS score 6-30 at the time of randomization; Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography(MRA) proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery; Imaging showed massive infarction: within 24h of onset and Alberta Stroke Program Early CT Score (ASPECTS) < 3, and large infarct core 70-100 ml (CT perfusion [ Relative Cerebral Blood Flow (rCBF) < 30%]); within 24h of onset and ASPCECTS score 3-5 (based on NCCT); ASPECTS > 5, within 6h-24h of onset,and large infarct core 70-100 ml (CTP [rCBF < 30%]); Successful recanalization of occluded vessel (modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3) after EVT; Patients and/or their families agreed to enter the trial. Exclusion Criteria: CT after reperfusion showed PH2 hemorrhagic transformation; bilateral stroke or multiple intracranial occlusions; known presence of Inferior Vena Cava (IVC) filter; end-stage renal disease on hemodialysis; known hemorrhagic diathesis, coagulation factor deficiency or platelet count < 5 × 109/L, International Normalized Ratio(INR) > 1.7; known hypersensitivity to meperidine, buspirone, midazolam and other sedative and analgesic drugs; pregnant women; combined malignant tumors, sepsis, hypothyroidism; unstable vital signs/dying state, requiring vasoactive drugs to maintain hemodynamic stability and in the incremental phase; cardiac function grade 4/severe liver and kidney dysfunction; has participated in other drugs or device clinical trials that may have an impact on the current study; other reasons lead the investigator to believe that patients are not suitable to continue hypothermia treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Study group
Control group
The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.
The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.