Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT05676957
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05676957
Study Brief:
Protocol Section:
NCT05676957