ACTRN12615000759594招募中2 期
Effect of angioplasty and stenting versus aggressive medical treatment on mortality and stroke in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort
Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university0 个研究点目标入组 198 人开始时间: 2015年7月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Patients aged from 18 to 70 years.
- •2. Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a stenosis from 70% to 99% in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
- •3. A length less than or equal to 15mm of a stenosis in the target vessel and a vessel size greater than or equal to 2mm.
- •4. Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
- •5. CT or MRI scans show no massive cerebral infarction (beyond half of the MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
- •6. Patients who understand the purpose of the study and have provided informed consent.
排除标准
- •1. Not able to receive general anesthesia.
- •2. Not able to receive angiographic assessment.
- •3. A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
- •4. 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.
- •5. A high risk (leading to a stroke or death) to deliver the stent to the lesion.
- •6. A previous stent or angioplasty in the target lesion.
- •7. Progressive neurological signs within 24 hours before enrolment
- •8. Any haemorrhagic infarct within 14 days before enrolment
- •9. The presence of a cardiac source of embolus
- •10. Thrombolytic therapy within 24 hours before enrollment
- •11. Presence of intraluminal thrombus proximal to or at the target lesion
- •12. Myocardial infarction within previous 30 days
- •13. 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.
- •14. Known contraindications for aspirin and clopidogrel treatment.
- •15. An modified Rankin score greater than or equal to 3.
- •16. With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
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