This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.
This is a multicenter, prospective, randomized, open-label, controlled trial with blinded outcome assessment (PROBE design) evaluating endovascular therapy (EVT) for patients with acute mild basilar artery occlusion (MBAO). Acute MBAO is defined as basilar artery occlusion confirmed by CTA/MRA/DSA, with mild neurological deficits (baseline NIHSS ≥2 and \<10). Participants will be randomized in a 1:1 ratio to receive either EVT plus best medical therapy or best medical therapy alone. The primary outcome is the rate of good functional status at 90 days after randomization was defined as the modified Rankin Scale (mRS) score of 0-2 at 90 days. 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
230
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
The rate modified Rankin Scale (mRS) score 0-2 at 90 days
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 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
The rate of 0-1 and 0-3 mRS scores after randomization for 90 days
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
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 (-6/+12) hours after randomization
NIHSS score at 7 days after randomization or discharge (whichever occurs first), as well as changes from baseline
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.
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Time frame: 7 days after randomization or at discharge
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score 90 days after randomization
EuroQol Five Dimensions (EQ-5D-5L) 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
Barthel index 95-100 points 90 days after randomization
The proportion of Barthel Index 95-100 at 90 days after randomization.
Time frame: 90±14 days after randomization
The recanalization of the basilar artery 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)
Basilar artery recanalization at 24 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
Time frame: 24 (-6/+12) hours after randomization
The technical success rate is defined as the successful recanalization of the target vessel at the end of the surgery (Extended Thrombolysis Classification for Cerebral Infarction [eTICI] 2b-3)
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (The expanded Thrombolysis in Cerebral Infarction (eTICI) scale eTICI 2b-3).
Time frame: At the end of the operation