Acute Ischemic Anterior Circulation Large Core Cerebral Infarction
Conditions
Interventions
Control group:endovascular thrombectomy
Test group:endovascular thrombectomy combined Intra-artery cold saline infusion
Sponsors
Yijishan Hospital of Wannan Medical college
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Pre-randomization NIHSS score >= 6; 3. Time from onset to randomization 5, additionally required to meet CTP core infarct volume of 70-100 ml.
Exclusion criteria
Exclusion criteria: 1. Pre-stroke mRS score > 1; 2. Multi-vessel occlusion; 3. Concomitant untreated intracranial aneurysm, intracranial tumor (excluding small meningioma), or intracranial vascular malformation; 4. History of intracranial hemorrhage within 6 months, including parenchymal hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage; 5. Gastrointestinal or urinary tract bleeding, acute myocardial infarction, traumatic brain injury, or major surgery within the past 1 month; 6. Active bleeding, coagulation disorders, or uncorrectable bleeding tendency: platelet count 2 on anticoagulant therapy (irreversible); 7. Cardiac function grade > 1, or a clear history of acute or chronic cardiac insufficiency, with a high risk of acute heart failure or intolerance to fluid infusion as judged by the clinician; 8. Severe cardiac, hepatic, or renal impairment, or other serious advanced diseases of any system; 9. Known allergy to iodinated contrast agents or other drugs used in the treatment; 10. Refractory hypertension poorly controlled by medication (defined as sustained systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) (Note: Patients whose blood pressure can be lowered and maintained at an acceptable level with medication may be included); 11. Uncontrolled blood glucose 22.2 mmol/L; 12. Pregnancy or breastfeeding; 13. Life expectancy < 1 year; 14. Currently participating in another clinical study that may affect outcome assessments; 15. Other conditions deemed by the investigator to be unsuitable for participation in this study or that may pose significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairments).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of 0–3 at 90 (+/-7) days after randomization.;Probability of sICH (Heidelberg criteria) occurring within 48 (+/-12) hours after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Shift analysis of mRS score improvement trend at 90 (+/-7) days after randomization;All-cause mortality at 90 (+/-7) days after randomization;The proportion of patients with an mRS score of 0–1 at 90 (+/-7) days after randomization.;The proportion of patients with an mRS score of 0–2 at 90 (+/-7) days after randomization.;Proportion of malignant brain edema occurrence;Probability of any type of intracranial hemorrhage (Heidelberg criteria) within 48 (+/-12) hours after randomization.; | — |
Countries
China
Contacts
Public ContactXianjun Huang
Yijishan Hospital of Wannan Medical college
Outcome results
None listed