Stroke
Conditions
Interventions
Experimental group:The patient received intravascular therapy (thrombectomy, stenting, aspiration, arterial thrombolysis, balloon dilatation and combination, etc.) within 24 hours of onset combined wi
Control group:The patients received standard medical treatment according to the current clinical management guidelines, including intravenous fibrinolysis, anticoagulant or antiplatelet therapy. If th
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Clinical symptoms meet the criteria for acute ischemic stroke and randomization can be completed within 24 hours after the onset of the stroke (the onset time is defined as the last known healthy time); 3. NIHSS score at randomization is 1-5; 4. DSA/CTA/MRA examination confirms intracranial large vessel occlusion; 5. ASPSECTS/pcASPSECTS score on CT/MRI at randomization is >= 6; 6. The patient or the patient's family signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI) that there is intracranial hemorrhage, brain edema or other obvious causes leading to the progression of symptoms; 2. Cerebral herniation causing displacement of the midline of the brain; 3. Pre-onset mRS score >= 2 points; 4. Pregnant or lactating women; 5. Genetic or acquired bleeding constitution, deficiency of anticoagulant factors; or having used anticoagulant drugs and INR > 3; 6. Life-threatening allergies to treatment-related drugs (known contrast agents, contrast media, vascular products); 7. Severe dysfunction of organs such as the heart, liver, and kidneys; 8. Refractory hypertension (defined as persistent systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and blood pressure cannot be controlled by antihypertensive drugs); 9. Baseline blood glucose 400 mg/dL ( > 22.20 mmol); 10. Known coagulation disorders, platelet count 3.0 mg/dL; 12. The target vessel may have factors hindering its completion of endovascular treatment, such as diameter < 1.5 mm, tortuous vascular path, difficulty in reaching the target position with the device, or difficult recovery; 13. Intracranial tumors with occupying effect (except for micro meningiomas) or intracranial vascular malformations on imaging; 14. Containing severe complications that may affect the prognosis and follow-up of the patient (cancer, severe heart failure, kidney failure); 15. Any disease at an advanced stage with an expected life expectancy of < 6 months; 16. Expected not to be able to follow the research procedures or complete the follow-up (such as inability to understand/and/or follow the research procedures and/or follow-up due to mental disorders, cognitive or emotional disorders); 17. Clinical history, previous imaging examinations and clinical judgment indicate chronic intracranial vascular occlusion; 18. Participating in clinical trials that may affect the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mrs score 0-1 at 90 days (%);Incidence of symptomatic intracranial hemorrhage (Sich) within 48 hours;90-day mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 day Mrs score improvement (shift analysis);Global Outcome Analysis(Including Barthel index=95,Glasgow Outcome score of 5, and mRS scale score of 0-1);Cosmos scale score;Mrs score 0-3 at 90 days (%);Mrs score 0-2 at 90 days (%);NIHSS score at discharge 5-7 days after onset or earlier;90 day EQ-5D scale score;Incidence of asymptomatic intracranial hemorrhage (asich) within 48 hours;Incidence of complications of non intracranial hemorrhage (including gastrointestinal bleeding, urethral bleeding, oral or nasal mucosal bleeding, subcutaneous hematoma, etc.);Incidence of non hemorrhagic serious adverse events (including cerebral hernia, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis and psychiatric symptoms); | — |
Countries
China
Contacts
Public ContactFayun Hu
West China Hospital, Sichuan University
Outcome results
None listed