This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
314
Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.
Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.
Xuanwu Hospital
Beijing, Beijing Municipality, China
Proportion of Patients Achieving mRS 0-3 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome.
Time frame: 90 days
Dramatic early favorable response
Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.
Time frame: 24 (-2/+12) hours
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Proportion of Patients Achieving mRS 0-4 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Barthel Index
The Barthel Index ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better outcomes.
Time frame: 90 days
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 6 months
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months
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The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 12 months
Proportion of basilar artery recanalization
Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades
Time frame: 24 hours (-2/+12 hours)