This multicenter, prospective, open-label randomized controlled trial with blinded assessment was designed to assess the efficacy and safety of endovascular treatment for progressive stroke due to vertebrobasilar artery occlusion.
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment (PROBE design) was designed to evaluate endovascular treatment (EVT) in patients with progressive stroke due to vertebrobasilar artery occlusion (VBAO). Progressive stroke due to VBAO was defined as vertebrobasilar artery occlusion confirmed by CTA, MRA, or DSA, accompanied by neurological deterioration occurring between 24 hours and 14 days after symptom onset, defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score resulting in a total NIHSS score ≥10 in patients with an initial NIHSS score \<10. Participants will be randomly assigned in a 1:1 ratio to receive EVT plus medical therapy or medical therapy alone. The primary endpoint is the proportion of patients with good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. Secondary outcomes include the distribution of mRS scores at 90 days, all-cause mortality at 90 days, and the incidence of symptomatic intracranial hemorrhage (sICH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
The endovascular approach is selected by the treating neurointerventionalists 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 deployment, or intraarterial 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 therapy is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Medical therapy 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 proportion of patients achieving modified Rankin Scale (mRS) score 0-3 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
Ordinal shift analysis of mRS score 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 proportion of patients achieving mRS scores 0-1 and 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
The National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
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
The NIHSS score at 7 days after randomization or discharge (whichever came 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
The score on the European Quality of life 5-Dimension 5-Level (EQ-5D-5L) patient-reported questionnaire score at 90 days
European Quality of life 5-Dimension 5-Level (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
The proportion of Barthel index 95-100 points at 90 days
The proportion of Barthel Index 95-100 at 90 days after randomization.
Time frame: 90±14 days after randomization
The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)
The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
Time frame: 24 (-6/+12) hours after randomization
The rate of technical success is defined as the successful recanalization of the target vessel at the end of the procedure (expanded Thrombolysis in Cerebral Infarction scale [eTICI] 2b-3)
Technical success rate, defined as successful recanalization of target vessels at the end of procedure (The expanded Thrombolysis in Cerebral Infarction scale \[eTICI\] 2b-3).
Time frame: At the end of the procedure