Lschemic Stroke
Conditions
Interventions
Endovascular Treatment Group:After enrollment, patients will receive endovascular treatment (EVT) combined with Best drug therapy (BMT). First, arterial thrombolysis was performed using tenecteplase (
Best Medical Management Group:Upon enrollment, patients will receive best medical management alone
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) Clinically diagnosed as acute ischemic stroke; 3) CT or MR Angiography confirmed isolated medium-sized distal vascular occlusion (i.e., occlusion of the M2 segment, M3/M4 segment of the middle cerebral artery, A1/A2/A3 segment of the anterior cerebral artery, or P1/P2/P3 segment of the posterior cerebral artery); 4) The time from the onset (or the last normal time) to the emergency department is less than 24 hours, and it does not meet the indications for intravenous thrombolysis; 5) Not having received intravenous thrombolysis treatment, and being evaluated by the treating clinical doctor as unsuitable for intravenous thrombolysis; 6) The score of The National Institutes of Health Stroke Scale (NIHSS) is >= 5 points, or the NIHSS score is <=4 points but accompanied by disabling neurological deficits (for example: Severe aphasia, hemianopia, hemiplegia/unilateral loss of function or fluctuating symptoms at randomization; 7) For patients within 6 hours of onset: In non-contrast CT (NCCT), no obvious low-density area was observed compared with the contralateral white matter, or no high signal was seen in the fluid-attenuated inversion recovery (FLAIR) sequence. For patients with onset within 6 to 24 hours: Perfusion imaging shows that the ischemic core mismatch ratio is greater than 1.2 and the infarcted core volume is less than 50 ml; For patients within 6 hours of onset: 8) The modified Rankin scale (mRS) score before stroke is less than or equal to 1 point; 9) The patient or the legally authorized representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Signs of intracranial hemorrhage indicated by baseline CT/MR; 2) Multiple (>=2) distal vascular occlusions exist simultaneously; 3) Vascular occlusion caused by suspected cerebrovascular inflammation, infectious embolism or infectious endocarditis; 4) Suspected arterial dissection; 5) Clinical assessment shows that interventional therapy is not suitable (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate 220µmol/L (2.5 mg/dl)) 6) Clinical assessment shows that arterial thrombolytic therapy is not suitable (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count 1.7); Oral anticoagulants were taken within 24 to 48 hours before the onset of the disease, and the APTT was more than three times the normal value. There is a recent history or clinical manifestations of brain tumors other than meningiomas 7) Any end-stage disease with an estimated survival time of less than 1 year; 8) Pregnant or lactating women; 9) Participate in research involving investigational drugs or devices that affect this study; 10) Other circumstances where the researcher deems participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excellent functional outcome(mRS 0-1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Good functional outcome(mRS 0-2);Distribution of functional outcome: The mRS score at 90 days and the utility weighted mRS;Quality of life measured using EQ-5D-5L at 90 days;Neurological status ;Early neurological improvement;Final infarct volume;Malignant cerebral edema;All-cause mortality;All-cause mortality; | — |
Countries
China
Contacts
Public ContactBo Wu
West China Hospital of Sichuan University
Outcome results
None listed