Study on Hibernation-like Therapy Based on Mechanical Thrombectomy

Más betegség

• Image exclusion criteria:
  • computed tomographic angiography（CTA）/magnetic resonance angiography（MRA）/digital substraction angiography（DSA） shows excessive vascular curvature, which may hinder delivery of interventional devices
  • Cerebrovascular inflammation is suspected based on medical history and CTA/MRA/DSA
  • Aortic dissection is suspected based on medical history and CTA/MRA/DSA
  • CTA/MRA/DSA confirmed multi-vascular regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral or multi-regional infarction
  • CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome
  • CT/MRI confirmed a significant midline shift effect
  • CT/MRI confirms the presence of intracranial tumors (except cerebellar meningioma) CT/MRI confirmed intracranial hemorrhage

Laborértékek

• Clinical Exclusion Criteria:
  • Clinical findings suggest intracranial parenchymal hemorrhage or subarachnoid hemorrhage.
  • Accompanied by epilepsy.
  • Accompanied by coma or mental disorders, may interfere with neurological function assessment.
  • History of premorbid phenothiazine allergy or contraindication.
  • History of allergy to iodine contrast medium or anaphylactic shock
  • Baseline blood glucose <50mg/dL (2.78mmol) or >400mg/dL (22.20mmol)
  • Acceptable fingertip blood glucose results
  • Baseline platelet <50×109 /L
  • Recent (i.e. within 30 days prior to randomization) history of gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal clotting factors, or bleeding tendency (INR≥3 or PT≥3×ULN on anticoagulants; If the investigator believes that the subject does not have coagulation dysfunction, it is not necessary to wait for the results of the coagulation test before deciding whether to enroll.)
  • The stroke is accompanied by fever, or there is an active infection requiring systemic treatment (such as active tuberculosis, etc.)
  • Expected survival less than 90 days (According to the Chinese Guidelines for Early Endovascular Interventional Diagnosis and Treatment of Acute Ischemic Stroke 2022, expected survival less than 90 days is a contraindication for endovascular therapy)
  • A history of severe cardiovascular disease, including but not limited to: uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg after standard treatment), hypotension (systolic blood pressure ≤100 mmHg after standard treatment), or pulmonary hypertension; Had unstable angina pectoris, myocardial infarction, or bypass or stent surgery within 6 months before randomization; New York Heart Association (NYHA) grade 3-4 history of chronic heart failure; Clinically significant valvular disease; Severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), including QT interval ≥450ms for men and ≥470ms for women
  • accompanied by chronic obstructive pulmonary disease（COPD）, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, respiratory irregularity and other lung diseases
  • Severe hepatic and renal insufficiency, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr<25ml/min), hepatorenal syndrome, etc
  • Pregnancy or lactating women
  • Participation in other clinical trials and have used an investigational drug or medical device
  • Patients that may not be able to complete the study for other reasons or who the investigator believes should not be included

• Clinical Inclusion Criteria:
  • Age between 18-80 years(including the critical value)
  • Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 6-20
  • Time from last known to be well to randomization within 24h
  • Pre-stroke Modified Rankin Scale scoring 0-1.
  • With indications of reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy).
  • Informed consent signed by patients or their legal relatives.
  • CT angiography (CTA) confirmed large vessel occlusion of anterior circulation
  • Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6-10.
  • initial infarct volume on CT perfusion (CTP) lesser than 70ml; a ratio of hypoperfused volume to infarcted volume greater than 1.8; absolute mismatch volume greater than 15 ml according to DEFUSE-3 trial.