To evaluate the efficacy and safety of endovascular therapy for posterior circulation ischemic stroke presenting more than 24 hours after symptom onset.
This study is a multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of endovascular treatment administered beyond 24 hours after the onset of posterior circulation ischemic stroke. A total of 244 patients (122 per group) will be enrolled, aged ≥18 years, with a baseline NIHSS score ≥4, onset of stroke or last known well time \>24 hours and within 14 days, and confirmed occlusion of the basilar artery or the intracranial segment of bilateral vertebral arteries as the culprit vessel. Patients will be randomly assigned to the experimental group (endovascular treatment plus standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is the proportion of patients with a 90-day modified Rankin Scale (mRS) score of 0-3. Secondary endpoints include the distribution of 90-day mRS scores, the proportion of patients with a 90-day mRS score of 0-2, and the 90-day EQ-5D-5L scale score. The study is led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology as the coordinating center and will be conducted at multiple centers across China, with a planned duration of 36 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Mechanical thrombectomy (stent retriever or aspiration) plus standard medical therapy (antiplatelet, statin, and risk factor control), specifically for posterior circulation stroke with onset \>24 h to ≤14 days.
Standard medical therapy: antiplatelet, statin, and vascular risk factor control per stroke guidelines, without endovascular intervention.
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProportion of patients with an mRS score of 0-3 at 90 days
Time frame: 90days
Symptomatic intracranial hemorrhage (sICH) (defined as a worsening of NIHSS by 4 or more points within 24 hours after random treatment, associated with intracranial hemorrhage)
Time frame: 24hours
Surgical-related complications
Time frame: Post procedure 24hours
Stroke-related mortality at 90 days
Time frame: 90days
EQ-5D-5L scale score at 90 days
Time frame: 90days
New onset of stroke within 90 days
Time frame: 90days
Hematoma of any type at 24 hours (-6/+24) after random treatment
Time frame: 24hours
The distribution of mRS scores at 90 days post-randomization
Time frame: 90days
All-cause mortality at 90 days
Time frame: 90days
Proportion of patients with an mRS score of 0-2 at 90 days
Time frame: 90days
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