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 at 24-48 hours; 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; residence; and hospital service costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
382
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
RECRUITINGFunctional recovery (level of disability)
Shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.
Time frame: 90 days
Neurological impairment
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: 24 hours and 7 days
Death or major disability
modified Rankin scale (mRS) 3-6
Time frame: 90 days
Separately on death and disability
modified Rankin scale (mRS) 3-5
Time frame: 90 days
Health-related Quality of Life (HRQoL)
using EQ-5D. European Quality of Life 5-dimensional questionnaire. The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: Higher scores mean a worse outcome.
Time frame: 90 days
Utility-weighted modified Rankin scale scores
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome. Higher scores mean a worse outcome.
Time frame: 90 days
Duration of hospitalization
Days of hospitalization
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Time frame: 90 days
Residence
Days of residence
Time frame: 90 days
Hospital service costs
Health economic measurement
Time frame: 90 days
Infarct volume on DWI, or CT
Infarct volume on DWI, or CT if DWI not feasible
Time frame: 24 hours
Recanalization
Recanalization confirmed on imaging
Time frame: 24 hours after MT