中国组织工程研究2016，Vol.20Issue(34)：5070-5075,6.DOI:10.3969/j.issn.2095-4344.2016.34.009
颅内自膨式支架Enterprise治疗缺血性脑卒中颈内动脉狭窄的远期效果：随机对照临床试验方案
Long-term effects of Enterprise self-expanding intracranial stent implantation in the treatment of carotid artery stenosis in patients with ischemic stroke：study protocol for a randomized controlled trial
摘要
Abstract
BACKGROUND:The Enterprise stent system is a closed-loop, recoverable self-expanding stent that is effective in the treatment of intracranial aneurysm. However, most studies on the treatment of intracranial aneurysm after ischemic stroke are case series or case reports. <br> OBJECTIVE:To assess the efficacy of the Enterprise stent system for the treatment of carotid artery stenosis in patients with atherosclerotic ischemic stroke. <br> METHODS:We wil perform a single-center, double-blind, randomized paralel-controled trial at the <br> Department of Neurology, Beijing Chao-yang Hospital, Capital Medical University, China. A cohort of 100 patients with atherosclerotic ischemic stroke wil be included after obtaining written informed consent from participantsor their guardians, and then randomly alocated to undergo either Enterprise self-expanding intracranial stent implantation in combination with antiplatelet medication (stent implantation group,n= 50) or only antiplatelet medication (drug group,n= 50) for treatment of carotid artery stenosis. Four time points (0.5, 1, 2, and 3 years after stent implantation or antiplatelet medication) wil be selected for outcome observation and evaluation. The primary outcome wil be the National Institutes of Health Stroke Scale score, which is used to evaluate neurologic deficits. The secondary outcomes wil be the Barthel index and carotid stenosis rate. The study protocol has been approved by the Ethics Committee of Beijing Chao-yang Hospital, Captical Medical University, China (approval number: GJCY16012) and wil be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. This trial was registered at ClinicalTrial.gov (NCT02802072). <br> DISCUSSION:There isa lack of randomized controled studies addressing the long-term effects of the Enterprise self-expanding intracranial stent system for carotid artery stenosis in patients with ischemic stroke. This study wil investigate and further confirm the clinical significance of the Enterprise stent system in the treatment of carotid artery stenosis in patients with ischemic stroke.关键词
生物材料/材料相容性/临床试验/颈动脉狭窄/Enterprise支架/镍钛支架系统/动脉粥样硬化/随机对照试验分类
医药卫生引用本文复制引用
纪蒙,王玮,胡文立..颅内自膨式支架Enterprise治疗缺血性脑卒中颈内动脉狭窄的远期效果：随机对照临床试验方案[J].中国组织工程研究,2016,20(34):5070-5075,6.基金项目
首都医学发展科研基金资助项目(2003-1002)@@@@theCapital Medical Science Development and Research Foundation, China, No.2003-1002 （2003-1002）
