Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.
Age ≥18 years
Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)
Modified Rankin Scale (mRS) score of 0-2
Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment
Evidence of hemorrhage on CT or MRI
Large hemispheric infarction involving >50% of the middle cerebral artery territory on CT or MRI
Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy <12 months
Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)
Parallel
Endovascular treatment
Procedure/SurgeryEndovascular 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
DrugStandard 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.
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.
Successful reperfusion rate
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.
Residual stenosis of target vessel at 12 months
The degree of target artery stenosis based on following-up neurovascular imaging
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