Ischemic stroke Circulatory System Ischemic stroke
Conditions
Interventions
Stent-assisted angioplasty of the offending intracranial stenosis plus optimal medical therapy versus optimal medical therapy alone
Sponsors
The Ministry of Health of the People's Republic of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-75 years of age 2. =1 major atherosclerotic risk factors (arterial hypertension, hyperlipidemia, diabetes mellitus, hyperhomocystinemia and smoking) 3. Recurrent ischemic events (transient ischemic attack [TIA] and/or stroke) attributed to an intracranial stenosis =50% at digital subtraction angiography (DSA) 4. Evidence of perfusion deficit at the territory referable to the target stenosis in computed tomography (CT)-perfusion 5. The diameters of the parent arteries were between 2.0 to 4.0 mm, and length of stenoses <12 mm 6. Modified Rankin score =2 prior to last ischemic event
Exclusion criteria
Exclusion criteria: 1. Stenosis of non-atherosclerotic origin (for example, vasculitis, Moya Moya disease and fibromuscular dysplasia) 2. Intracranial hemorrhage and major ischemic stroke (National Institutes of Health-Stroke-Scale [NIHSS] =8) in the same hemisphere as the target lesion within 6 weeks 3. A potential source of cardiac embolism 4. Concurrent intracranial tumors, cerebral arteriovenous malformation (AVM) and aneurysms 5. Presence of a neurological illness that can confound the diagnosis of TIA or stroke 6. Known contraindication to aspirin, clopidogrel, probucol, heparin, stainless steel, anesthesia, or X-ray contrast 7. Uncorrectable bleeding diathesis; previous stenting of the target artery 8. A positive pregnancy test 9. Life expectancy <1 year because of other medical conditions 10. Patients were not eligible if they could not cooperate with the study procedures or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ipsilateral stroke, fatal or non-fatal, within 12 months 2. Events of clinically-driven emergency revascularization related to the treated stenosis 3. Modified Rankin score in 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stroke and death unrelated to the target stenosis 2. Acute myocardial infarction in 12 months 3. Follow up cerebral angiography or magnetic resonance (MR) angiography, CT and CT-perfusion in 6 months 4. NIHSS in 12 months | — |
Countries
China
Outcome results
None listed