Symptomatic Intracranial Atherosclerotic Stenosis/Occlusion
Conditions
Interventions
Treatment arm:? Single Antiplatelet Therapy:Regimen post-enrollment: Aspirin 100 mg once daily OR Clopidogrel 75 mg once daily [OR Ticagrelor 90 mg twice daily] Minimum 3 days of pre-operative antipla
Blood pressure control(Target <140/90 mmHg (<130/80 mmHg for diabetic participants))
Lipid control(LDL-C <70 mg/dL)
Glycemic control(HbA1c <7%)
Lifestyle interventions(Smoking cessation, weight management, physical exercise)
? Multimodal Cerebral Indirect Revascularization Surgery: Timing: Performed within 1-5 working days post-enrollment
Surgical modalities (individualized selection),
Control arm:? Single Antiplatelet Therapy:Regimen post-enrollment: Aspirin 100 mg once daily OR Clopidogrel 75 mg once daily [OR Ticagrelor 90 mg twice daily] Minimum 3 days of pre-operative antiplate
Sponsors
Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Aged 18–80 years; 2 Unilateral intracranial internal carotid artery (ICA) or middle cerebral artery (MCA) stenosis >=70% or occlusion confirmed by digital subtraction angiography (DSA); 3 Modified Rankin Scale (mRS) score =1 month before enrollment; 6 Neurological deficits persisting for >=1 month; 7 CT perfusion (CTP) demonstrating hypoperfusion in the affected territory (mean transit time [MTT] >=4 s and relative cerebral blood flow [rCBF] ratio <0.95); 8 Poor collateral circulation (American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology [ASITN/SIR] collateral score 0–2) on DSA; 9 Capacity to understand and provide informed consent; 10 Residing within geographical proximity to enable study follow-up.
Exclusion criteria
Exclusion criteria: 1 Concurrent cerebrovascular pathologies (e.g., cerebral aneurysm, arteriovenous malformation [AVM], moyamoya disease); 2 Stenosis >=50% or occlusion in non-target arteries (contralateral ICA/MCA, basilar artery) confirmed by DSA; 3 Large cerebral infarction (>5 cm diameter) on MRI with significant risk of hemorrhagic transformation; 4 Unstable angina or myocardial infarction within the past 6 months; 5 Cardiac conditions predisposing to cerebral ischemia (e.g., atrial fibrillation, valvular heart disease); 6 Coagulopathy (INR >1.5, platelet count 16.7 mmol/L in participants with diabetes; 8 Pregnancy or lactation; 9 Life-threatening comorbidities (e.g., metastatic cancer, end-stage renal disease); 10 Contraindications to aspirin/clopidogrel therapy; 11 Hypersensitivity to iodine-based contrast agents; 12 Severe hepatic/renal dysfunction (ALT/AST >3× upper limit of normal [ULN]; serum creatinine >3 mg/dL); 13 Prior revascularization surgery (angioplasty, stenting) on target vessels; 14 Poorly controlled hypertension (systolic >=180 mmHg or diastolic >=110 mmHg); 15 History of primary intracerebral hemorrhage; 16 Intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days; 17 Previous stent/angioplasty treatment of target lesions or planned staged interventions; 18 Extracranial/intracranial stenting/angioplasty/endarterectomy within 30 days pre-enrollment; 19 Active smoking within the past 6 months or BMI >35 kg/m²; 20 Concurrent participation in other interventional trials; surgeon-deemed surgical ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of stroke or death at 30 days;Ipsilateral ischemic stroke occurring between 30 days and 2 years post-enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major TIA within 30 days post-enrollment;TIA, any stroke, or all-cause death from 30 days to 24 months post-enrollment;Comprehensive neurological function improvement/preservation at 12 & 24 months;Multimodal imaging assessments at 1, 6, 12, 24 months;Surgery-related complications within 30 days post-enrollment; | — |
Countries
China
Contacts
Public ContactLiu Yi
Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Outcome results
None listed