Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 394
- 主要终点
- Proportion of patients with events of stroke or death
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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≥
- •With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
研究组 & 干预措施
stenting+medical treatment
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
干预措施: Percutaneous transluminal angioplasty and stenting (Procedure)
stenting+medical treatment
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
干预措施: Aspirin plus clopidogrel (Drug)
Aspirin plus clopidogrel
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
干预措施: Aspirin plus clopidogrel (Drug)
结局指标
主要结局
Proportion of patients with events of stroke or death
时间窗: at 30 days after randomization
次要结局
- neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)(30 days and 1 year after randomization)
- Proportion of patients with adverse events(30 days and 1 year after randomization)
- the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory(30 days and 1 year after randomization)
研究者
Feng-Feng Shen
Doctor
The 476th Hospital of People's Liberation Army