Progressive Acute Mild Ischemic Stroke
Conditions
Interventions
BMM+EVT group:Remedial intravascular therapy combined with optimal drug therapy
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. signs and symptoms consistent with basilar area ischemia; 3. basilar or vertebral artery occlusion confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA)/digital basilar angiography (DSA); If vertebral artery occlusion occurs, blood flow along the basilar artery should be completely prevented; 4. Presenting with symptoms consistent wiht an mild ischemic stroke and the initial NIHSS score =4 points or consciousness level score increased by >=2 points compared with the first NIHSS score; 7. Randomization can be finished > 24 hours of stoke onset(stroke onset time is defined as last known well time);); 8. Symptom progression to randomization time =10 points; 10. Informed consent signed;
Exclusion criteria
Exclusion criteria: 1. Progression of symptoms due to intracranial hemorrhage, cerebral edema, or other definite causes (including but not limited to hemorrhagic transformation of infarction, new infarction of non-occlusive vascular area, severe infection, high fever, cardiac and renal insufficiency, low blood volume, or severe electrolyte disturbance); 2. Pre-stroke mRS score >2; 3. The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery; 4. Severe stenosis or occlusion of multiple blood vessels; 5. Previous imaging confirmed or investigators believed that the patient had chronic basilar artery occlusion; 6. Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations; 7. Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage; 8. Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month; 9. Active bleeding, coagulation dysfunction, or a tendency to bleed irremediably:; 10. Baseline platelet count 2(irreversible);); 11. Severe heart, liver, kidney function damage or other severe late stage diseases of the system; 12. Known allergies to treatment related drugs such as iodine contrast agents, etc; 13. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg); 14. Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l); 15. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test; 16. The expected survival time is less than 0.5 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.); 17. Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial; 18. Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| favorable outcomes mRs Scores 0-3 at 90 (+/-7) days after randomization;Incidence of symptomatic intracerebral haemorrhage (sICH) within 24 (±6) hours after randomization (Heidelberg haemorrhage classification); | — |
Secondary
| Measure | Time frame |
|---|---|
| Shift analysis of mRs score improvement trend after randomization for 90 (+/- 7) days;Proportion of mRs Scores 0-2 at 90 (+/-7) days after randomization;EQ-5D-5L scale scores at 90 (+/-7) days after randomization;Change of NIHSS score from baseline 24 hours after EVT;Changes in NIHSS scores from baseline after discharge or 5-7 days after EVT;Successful recanalization (eTICI classification);Incidence of any intracranial hemorrhage within 24 (±6) hours after randomization (Heidelberg hemorrhage classification);All-cause mortality at 90 (+/-7) days after randomization; | — |
Countries
China
Contacts
Public ContactXianjun Huang
Yijishan Hospital of Wannan Medical college
Outcome results
None listed