This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial
This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
308
The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame: 90±14 days after randomization
MRS score as an ordinal scale at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame: 90±14 days after randomization
Rate of mRS 0-2 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame: 90±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
The National Institute of Health Stroke Scale(NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: 24 hours after randomization
NIHSS score at 7 days after randomization or discharge (whichever came first)
The National Institute of Health Stroke Scale(NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: 7 days after randomization or at discharge
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Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization
EuroQol Five Dimensions (EQ-5D) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Time frame: 90±14 days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization.
Time frame: 90±14 days after randomization
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD)
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
Time frame: 18-36 hours after randomization
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3)
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3).
Time frame: At the end of the operation
The proportion of mRS 0-4 at 90 (± 14) days after randomization
The proportion of mRS 0-4 at 90 (± 14) days after randomization.
Time frame: 90±14 days after randomization