Acute Ischemic Stroke, Endovascular Treatment, Mild Stroke, Perfusion Imaging
Conditions
Keywords
MILD-MT, Mild stroke
Brief summary
Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening
Detailed description
This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.
Interventions
OTHERExperimental group:Intervention Group
Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines.
Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.
Sponsors
Zhangzhou Municipal Hospital
Changhai Hospital
The Affiliated Hospital Of Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Endpoint-blined
Intervention model description
Intervention group: Endovascular treatment Control group:Best medical treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years old; 2. Symptoms onset or last known well to randomization is within 24 hours. 3. Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery \[ICA\], middle cerebral artery \[MCA\] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ; 4. Baseline NIHSS score \<6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization); 5. ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) \<30%/DWI-ADC\<620) ≤50ml, and mismatch volume (Tmax\>6 seconds volume - rCBF \<30% /DWI-ADC\<620) ≥50mL; 6. The patient or their legal representatives voluntarilysigned the informed consent form. Clinical
Exclusion criteria
1. Premorbid Rankin Scale (mRS) score ≥ 1; 2. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure; 3. Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months); 4. Poorly controlled hypertension (systolic blood pressure \>220 mmHg or diastolic blood pressure \>120 mmHg); 5. Baseline blood glucose \<50mg/dL (2.78 mmol/L) or \>400mg/dL (22.20 mmol/L); 6. Known bleeding tendencies, including but not limited to platelet count \<100×109/L; received heparin treatment within 48 hours with an activated partial thromboplastin time (APTT) ≥35s; recent oral anticoagulant therapy with international normalized ratio (INR) \>3; Note: Patients without a history of coagulation abnormalities or without suspicion of coagulation abnormalities do not need to wait for laboratory test results before enrollment; 7. Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score; 8. Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission; 9. Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study; 10. Other conditions deemed unsuitable for participation, in the opinion of the investigator, or that may pose significant risks to the patient if participating the study. Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of excellent outcome at () days | 90±7 days | mRS score 0-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS shift | 90±7 days | distribution of mRS scores |
| proportion of subjects with good neurological function prognosis | 90±7 days | mRS score 0-2 |
Countries
China
Contacts
STUDY_DIRECTORWenhuo Chen, MD
Fujian Medical University Union Hospital
Outcome results
None listed