About this trial
Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END).
Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials.
The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older;
The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
Altered mental status (lethargy or worse);
Facial palsy (facial weakness score ≥ 1 point);
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Endovascular therapy
Procedure/SurgeryDrug: Best medical management All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Procedure: Endovascular therapy In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.
Best medical management
DrugAll the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
Treatment groups
Trial outcomes
Primary outcomes
90-day excellent clinical outcome
modified Rankin scale score: 0-1; , 0 \[no disablility\] to 6 \[death\]
Secondary outcomes
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
All-cause mortality rate
All-cause mortality rate
Good clinical outcome
modified Rankin Scale score: 0-2; 0 \[no disablility\] to 6 \[death\]
90-day ordinal modified Rankin Scale score shift
ordinal modified Rankin Scale score shift; 0 \[no disablility\] to 6 \[death\]
Other outcomes
incidence of adverse events
Any ICH post-randomization; vessel perforation; embolus migration in a new territory; rescue endovascular treatment; acute coronary syndrome, venous thrombosis or embolus events; brain herniation, and pneumonia, respiratory failure, circulatory failure, stress ulcers, renal failure, etc.
Sponsors and contacts
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