symptomatic intracranial atherosclerosis stenosis
Conditions
Interventions
Control group:optimal medication treatment
FDA approved stenting group:Stent implantation approved by the FDA for ICAS combined with optimal drug therapy
non-FDA approved stenting group:Stent implantation unapproved by the FDA for ICAS combined with optimal drug therapy
Sponsors
Xinqiao Hospital, the Third Military Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 years or older; 2) mRS score = 200cm/s; 8) Large arterial atherosclerosis of TOAST subtypes; 9) written informed consents.
Exclusion criteria
Exclusion criteria: 1) Acute ischemic stroke in the last 1 weeks; 2) Tandem extracranial stenosis (>50 %) or occlusion that is proximal l to the target intracranial lesion; 3) Perforator artery strokes; 4) Severe calcification at target lesion; 5) Severe vascular tortuosity or anatomy that would preclude stenting or angiography; 6) Thrombus is present at target artery or its proximal; 7) Non-atherosclerotic intracranial stenosis, including arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; 8) Potential cardiac embolism; 9) Concomitant intracranial tumour, aneurysm or arteriovenous malformation; 10) A history of intracranial or extracranial stent implantation angioplasty or endarterectomy; 11) Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, or epidural) hemorrhage within 30 days; 12) Rt-PA treatment within 24 hours before enrollment; 13) Neurological deterioration within 24 hours before enrollment; 14) Myocardial infarction within previous 30 days; 15) Major surgery (including open femoral, aortic or carotid surgery) within the last 1 month; 16) Allergic to and known contraindications for medications (heparin, contrast agents, aspirin and clopidogrel) or operating devices; 17) Ejection fraction 400mg/dl (22.2mmol/L); 19) Severe liver impairment (AST or. ALT >3 times normal, cirrhosis)severe renal insufficiency (eGFR 1.5: 22) Warfarin or heparin beyond the guidelines; 23) Alzheimer's disease or mental illness; 24) Pregnant or lactating women, or those planning to become pregnant within one year; 25) Life expectancy of < 1 year; 26) Unable to complete the follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any symptomatic stroke, TIA or death within 90 d;Target Vessel Stroke, TIA or death event within 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any symptomatic stroke, TIA or death within 30 d;Target Vessel Stroke event, TIA or death within 30 days;procedural complications;NIHSS score at baseline, 90 days and 1 year of follow-up;mRS score at baseline, 30 days, 90 days, 6 months and 1 year of follow-up;Stent restenosis within 90 daya and 1 years of follow-up;Cardiovascular events associated with stenting or drug withiin 90 days, 6 months, and 12 months of follow-up;Compliance with medication within 90 days, 6 months and 1 year of follow-up;Anisotropy and mean dispersion coefficient of MRI diffusion tensor imaging (intensity 3.0t) within 12 months of follow-up;Incidence of non-hemorrhagic adverse events; | — |
Countries
China
Contacts
Public ContactQingwu Yang
Xinqiao Hospital, the Third Military Medical University
Outcome results
None listed