Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.
This study is a multicenter, outcome-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular therapy combined with standard medical therapy versus standard medical therapy alone in patients with chronic intracranial artery occlusion. A total of 382 patients (191 per group) aged ≥18 years with chronic occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery confirmed by CTA, MRA, or DSA will be enrolled and randomly assigned to the experimental group (endovascular therapy + standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is stroke or death within 30 days after enrollment, or any ischemic stroke related to the responsible artery occurring from 30 days to 12 months after enrollment. Secondary endpoints include any stroke or death within 30 days after randomization; any stroke within 12 months after the procedure; disabling stroke within 12 months after the procedure; fatal stroke within 12 months after the procedure; any death within 12 months after the procedure; mRS score at 12 months; NIHSS score at 12 months; successful reperfusion rate of endovascular therapy; and procedure-related complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
382
Endovascular recanalization therapy for chronic atherosclerotic intracranial artery occlusion, including balloon angioplasty and/or stent implantation (e.g., self-expanding or drug-eluting stents) targeting the occluded unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery. The procedure is performed under local or general anesthesia via femoral or radial arterial access, with peri-procedural dual antiplatelet therapy (e.g., aspirin plus clopidogrel) management according to standard institutional protocols.
Standard pharmacological treatment: dual antiplatelet (aspirin 100 mg + clopidogrel 75 mg daily) for first 90 days, then single antiplatelet; high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily) targeting LDL-C \<1.8 mmol/L; strict BP control (\<140/90 mmHg, or \<130/80 mmHg in diabetics) and glycemic control (HbA1c \<7.0%); uniformly applied across centers with pill-count adherence monitoring.
Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment
A stroke is defined as rapid loss of neurological function due to ischaemia or a haemorrhage. CT or MRI scanning is necessary to identify the stroke.
Time frame: Within 30 days post-enrollment; and 30 days to 12 months post-enrollment
Disabling stroke within 12 months post-procedure
Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. CT or MR scans will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.
Time frame: 12 months post-procedure
Successful reperfusion rate
Time frame: End of the procedure
Any stroke within 12 months post-procedure
Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. Additional key neuro-images (CT or MR scans) will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.
Time frame: 12 months post-procedure
Residual stenosis of target vessel at 12 months
The degree of target artery stenosis based on following-up neurovascular imaging
Time frame: 12 months post-procedure
Fatal stroke within 12 months post-procedure
A cerebrovascular event that directly causes death or leads to irreversible brain damage resulting in imminent death based on CT or MR scans
Time frame: 12 months post-procedure
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NIHSS score at 12 months
The National Institutes of Health Stroke Scale (NIHSS) Scores range from a minimum of 0 (normal) to a maximum of 42 (profound impairment). Higher scores indicate a worse outcome, as they correspond to more severe stroke symptoms and poorer long-term prognosis.
Time frame: 12 months post-procedure
mRS score at 12 months
Modified Rankin Scale:1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6
Time frame: 12 months post-procedure
Any death within 12 months post-procedure
Time frame: 12 months post-procedure
Any stroke or death within 30 days post-randomization
Time frame: Within 30 days post-randomization
Procedure-related complications
Time frame: Perioperative period / Within 30 days post-procedure