Inclusion criteria
| Criteria |
|---|
| 1) Eligible patients between 30 and 80 years of age; intracranial arterial stenosis will not be considered if related to the following: nonatherosclerotic factors: arterial dissection, Moyamoya disease; vasculitic disease; herpes zoster, varicella zoster, or other viral vasculopathies; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of the central nervous system; postpartum angiopathy; suspected vasospastic process; and suspected recanalized embolus |
| 2) Symptomatic intracranial stenosis: presenting with TIA or stroke within the past 12 months attributed to 70%–99% stenosis of a major intracranial artery (internal carotid artery, MCA [M1], vertebral artery, or basilar artery) |
| 3) Degree of stenosis: 70%–99% severity confirmed by catheter angiography for enrollment in the trial |
| 4) Remote infarctions on MRI were acceptable, which could be accounted for by the occlusion of the terminal cortical branches or hemodynamic compromise (perforator strokes excluded); perforator strokes due to perforator occlusion are defined as basal ganglia or brain stem/thalamus infarction related with middle cerebral artery or basilar artery stenosis |
| 5) Expected ability to deliver the stent to the lesion |
| 6) All patients should be treated beyond a duration of 3 weeks from the latest ischemic symptom onset |
| 7) No recent infarctions identified on MRI (indicated as high signals on DWI series) at enrollment |
| 8) No massive cerebral infarction (more than one-half of the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI |
| 9) mRS score of ≤2 |
| 10) Target vessel reference diameter must be measured at 2.00–4.50 mm; target area of stenosis is ≤14 mm in length |
| 11) No childbearing potential or has a test negative for pregnancy within the week prior to study procedure; female patients had normal menses in the past 18 months |
| 12) Patient is willing and able to return for all follow-up visits required by the protocol |
| 13) Patients understand the purpose and requirements of the study and have signed an informed consent form |