Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score \>5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (\>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.
Age ≥ 18 years；
Presenting with symptoms consistent with an AIS and the initial NIHSS score <6 points；
Symptom progression within 7 days of first onset；
Randomization can be finished > 24 hours of stroke onset (stroke onset time is defined as last known well time)；
Pre-stroke mRS score >1;
Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
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;
Severe stenosis or occlusion of multiple blood vessels;
Parallel
Endovascular therapy
Procedure/SurgeryPatients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. 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
90-day good clinical outcome
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
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.
Neurofunctional deficit defined as modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
90-day clinical outcome
mRS 0-3 outcome
Change of infarct volume from baseline to 7 days
The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10-6mm2/s or on CTP image with rCBF\<30%
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First Affiliated Hospital of Wannan Medical College
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Xiangtan Central Hospital
Collaborator
The First Affiliated Hospital of Hainan Medical University
Collaborator
Huang Shan People's Hospital
Collaborator
Fuyang people's hospital
Collaborator
Linyi People's Hospital
Collaborator
Jiujiang No.1 People's Hospital
Collaborator
Taihe Hospital
Collaborator
