镍钛Smart支架系统治疗重度动脉粥样硬化性颈动脉狭窄：回顾性非随机对照临床试验方案.doc.docVIP

镍钛Smart支架系统治疗重度动脉粥样硬化性颈动脉狭窄： 回顾性非随机对照临床试验方案 马志刚，孙玉衡，彭晓新，胡洪涛(北京积水潭医院神经内科，北京市 100035) 引用本文：马志刚，孙玉衡，彭晓新，胡洪涛. 镍钛Smart支架系统治疗重度动脉粥样硬化性颈动脉狭窄：回顾性非随机对照临床试验方案[J].中国组织工程研究，2016，20(30):4554-4560. DOI: 10.3969/j.issn.2095-4344.2016.20.021 ORCID: 0000-0002-9640-774X(马志刚) 文章快速阅读： 文题释义： 颈动脉狭窄：镍钛Smart支架系统：Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective non-randomized controlled trial Ma Zhi-gang, Sun Yu-heng, Peng Xiao-xin, Hu Hong-tao (Department of Neurology, Beijing Jishuitan Hospital, Beijing 100035, China) Abstract BACKGROUND: The self-expanding Smart nitinol stent system is a popular treatment for carotid artery stenosis, because it is easy to manipulate and deploy, and endothelialization is rapid. OBJECTIVE: To assess the efficacy of Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis. METHODS: We conducted a retrospective, single-center, non-randomized, parallel controlled trial. A cohort of 103 patients with severe atherosclerotic carotid stenosis was included in the analysis after obtaining written informed consent from participants or their guardians. Treatment was undertaken according to each patient’s wishes after weighing the options: a Smart nitinol stent system (Cordis Corporation, Miami, FL, USA) was used in 40 patients, while 63 were managed conservatively with antiplatelet drugs. The primary outcome is the degree of disability of dependence 2 years after treatment, assessed by the modified Rankin Scale. The secondary outcomes are mRS scores 90 days and 1 year after treatment, recurrence of cerebrovascular events, and severity of neurologic deficit measured using the National Institutes of Health Stroke Scale 1 and 2 years after treatment. The study protocol was approved by the Ethics Committee of Beijing Jishuitan Hospital, China (approval number: 201605-01) and conducted in accordance with the guidelines of the Declaration of Helsin