Endovascular therapy (EVT) is currently recommended as the first-line treatment for patients with acute large vessel occlusion (LVO) in the anterior circulation within 24 hours of symptom onset. However, the therapeutic benefit of EVT beyond 24-hour window remains uncertain due to limited evidence. The EVT-BELATED trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the safety and efficacy of EVT in patients with acute ischemic stroke (AIS) caused by anterior circulation LVO presenting beyond 24 hours after symptom onset.
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age \>18 years) presenting with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO), either with a time window of 24 to 120 hours from symptom onset or last known well or progressive ischemic stroke with a time from symptom onset of 24 hours to 7 days. Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with endovascular therapy (EVT). EVT procedures may include mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty, or stenting, as deemed appropriate by the treating physician. The primary objective of the study is to evaluate the safety and efficacy of EVT in patients presenting with AIS due to anterior circulation LVO beyond 24 hours from symptom onset. The primary endpoint is functional independence at 90 days, defined as a score of 0-2 on the modified Rankin Scale (mRS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
432
EVT procedures may include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, or stenting, or other intra-arterial procedures as deemed appropriate by the treating physician.
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
The Second (Affiliated) Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGFunctional independence
The proportion of patients achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Time frame: 90 ± 7 days
Ordinal distribution of mRS
Ordinal distribution of the modified Rankin Scale (mRS) at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Time frame: 90 ± 7 days
Excellent functional outcome
Number of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Time frame: 90 ± 7 days
Poor functional outcome
Number of participants achieving a poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days follow-up. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Time frame: 90 ± 7 days
Early neurological deterioration
The proportion of patients with an increase of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score, within 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Time frame: 24 ± 12 hours
Any neurological improvement
The proportion of patients with a reduction of ≥ 2 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Time frame: 24 ± 12 hours
Early neurological improvement
The proportion of patients with a reduction of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Time frame: 24 ± 12 hours
Any new ischemic stroke events
Any new ischemic stroke events within 3 months
Time frame: 3 months
Any ischemic stroke event or revascularization
Any ischemic stroke event or revascularization of the culprit vessel between 3 and 12 months post-randomization.
Time frame: 3-12 months
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