Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion

Ki vehet részt

• 1.Age ≥18 years and ≤80 years
• 2.Symptoms and signs consistent with anterior circulation ischemia
• 3.Computed tomography angiography (CTA) /magnetic resonance angiography (MRA) /digital subtraction angiography (DSA) confirmed occlusion of intracranial segment of internal carotid artery (ICA) or M1/M2 segments of the middle cerebral artery (MCA M1/M2)
• 4.Acute ischemic stroke (AIS) selected for emergency endovascular treatment
• 5.Premorbid mRS ≤1
• 6.Time from symptom onset to randomization was within 24 hours, including patients with wake-up stroke or unwitnessed stroke; The time of symptom onset was defined as the Last Known Well (LKW)
• 7.National Institutes of Health Stroke Score (NIHSS) ≥6 at admission
• 8.ASPECTS ≥3
• 9.Informed consent obtained from the patient or his/her legal representative

Ki nem vehet részt

• 2.Baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation
• 7.Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs
• 3.Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• 5.Allergy to GM1 or excipients
• 6.Severe contrast allergy or absolute contraindication to iodinated contrast
• 15.Evidence indicates intracranial tumors (excluding small meningiomas), acute intracranial hemorrhage, tumors, or arteriovenous malformations (AVMs)
• 17. The patient has neurological disease or mental disorder before onset, which affects the assessment of the condition
• 19.Hereditary glycolipid metabolic disorders (ganglioside storage diseases, such as familial amaurotic idiocy, retinal degenerative diseases)
• 20.Autoimmune diseases, spine injuries, demyelinating diseases (e.g., Guillain-Barre syndrome)
• 8.Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L)
• 9.Platelet <50*10\^9/L
• 10.Known genetic or acquired bleeding diathesis, deficiency of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours
• 11.Known Severe renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) <30, or patient requires hemodialysis or peritoneal dialysis
• 1.Simultaneous acute occlusion of large vessels in both the anterior and posterior circulation or bilateral cerebral hemispheres
• 4.Bilateral dilated pupils
• 12.Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)
• 13.Presumed vasculitis or septic embolization
• 14.Suspicion of aortic dissection
• 16. Significant mass effect causing midline shift
• 18.Females who are pregnant or in lactation
• 21.Participating in other clinical trials that could confound the evaluation of the study
• 22.Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients