angioplasty and stenting for patients with symptomatic intracranial atherosclerosis

Conditions: Intracranial Atherosclerosis

Summary: background: effectiveness of percutaneous transluminal angioplasty and stenting (ptas) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (icas) is controversial. aim: to determine whether ptas plus medical treatment (mt) are superior to mt alone in preventing events of stroke and death in patients with symptomatic icas. methods: the investigators will carry out a randomized controlled trial in 3 hospitals in china. a total of 198 patients with icas will be randomized into 2 groups: ptas+mt and mt group. all patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in ptas+mt group will receive surgery within 5 days after randomization. the patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.


Eligibility criteria:
inclusion criteria: * patients aged from 18 to 70 years. * complaints of a symptomatic icas: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery. * a length ≤ 15mm of a stenosis in the target vessel and a vessel size \>2.5mm. * hypoperfusion in the territory of the target vessels, which is determined by ct or mri in 14 days before stenting. * ct or mri scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (mca)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor. * patients who understand the purpose of the study and have provided informed consent. exclusion criteria: * not able to receive general anesthesia. * not able to receive angiographic assessment. * a stenosis \>50% in an extracranial carotid or vertebral artery on the ipsilateral side. * infarctions due to the perforators occlusion (determined by mri scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis. * a high risk (leading to a stroke or death) to deliver the stent to the lesion. * a previous stent or angioplasty in the target lesion. * progressive neurological signs within 24 hours before enrolment * any haemorrhagic infarct within 14 days before enrolment * the presence of a cardiac source of embolus * thrombolytic therapy within 24 hours before enrollment * presence of intraluminal thrombus proximal to or at the target lesion * myocardial infarction within previous 30 days * non-atherosclerotic lesions: 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. * known contraindications for aspirin and clopidogrel treatment. * an modified rankin scale≥3. * with a childbearing potential or a positive pregnancy test in 1 week before enrolment.