A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; Barthel Index; and hospital service costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
336
Subjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes.
Changhai Hospital
Shanghai, China
Functional recovery (level of disability)
A sequence shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.
Time frame: at 90 days
Neurological function
Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome.
Time frame: at 24 hours and 7 days
Death or major disability
mRS 3-6
Time frame: at 90 days
Major disability
mRS 3-5
Time frame: at 90 days
Death
Death from any cause
Time frame: within 90 days
Utility-weighted modified Rankin scale scores
Utility-weighted mRS scores calculated by utility weights. A higher score indicates a better outcome
Time frame: at 90 days
Health-related Quality of Life (HRQoL)
Using the EuroQol 5 Dimension 5 Level (EQ 5D 5L) questionnaire. The EQ 5D 5L comprises five dimensions of health: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five severity levels (no problems, slight problems, moderate problems, severe problems, and extreme problems)
Time frame: at 90 days
Barthel Index
The total score ranges from 0 to 100, with higher scores indicating greater independence in self care
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Time frame: at 90 days
Infarct volume
Measured on follow-up CT/MRI
Time frame: at 7 days
Recanalization
Assessed by CTA/MRA
Time frame: at 48 hours