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  

Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective non-randomized controlled trial

作　　者：马志刚[1] 孙玉衡[1] 彭晓新[1] 胡洪涛[1] 

机构地区：[1]北京积水潭医院神经内科,北京市100035

出　　处：《中国组织工程研究》2016年第30期4554-4560,共7页Chinese Journal of Tissue Engineering Research

基　　金：首都医学发展科研基金资助项目(2003-1002)~~

摘　　要：背景:研究已证实,自膨式支架镍钛Smart支架系统具有柔软性好,径向张力均匀,弹性好,易于内皮化等优点,临床上已用于颈动脉狭窄的治疗。目的:评价镍钛支架系统S mart支架置入对重度动脉粥样硬化性颈动脉狭窄治疗的有效性。方法:研究为回顾性、单中心、非随机平行对照试验。试验取得患者及其监护人的书面知情同意后,根据患者意愿,给予纳入重度动脉粥样硬化性颈动脉狭窄患者103例中的40例Smart支架置入,63例抗血小板药物治疗。试验的主要结局为治疗后2年以改良Rankin量表评估患者的功能预后,次要结局为治疗后90 d,1年改良Rankin量表评估患者的功能预后,以及治疗后1和2年血管事件发生率及美国国立卫生研究院脑卒中量表评估的神经功能缺损程度。研究方案取得中国北京积水潭医院医院伦理委员会的书面批准(批准号:积伦科审字第201605-01号),且符合世界医学会制订的《赫尔辛基宣言》,同时已在C linical Trial.gov注册(NCT02800174)。讨论:目前关于镍钛S mart自膨式支架置入治疗重度动脉粥样硬化性颈动脉狭窄的研究主要是自身前后对照设计,且样本量较小,随访时间较短,不能充分说明S mart自膨式支架的临床应用是否可以获得良好的远期功能预后和减少血管事件的再发生。试验旨在通过涉及2年远期随访和较大样本量的非随机对照试验,从更严谨的角度证实S mart自膨式支架置入治疗重度动脉粥样硬化性颈动脉狭窄的远期效果。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 Helsinki, formulated by the World Medical Association. This trial was registered at ClinicalTrial.gov （NCT02800174）. DISCUSSION： Previous studies of the Smart nitinol stent system for the treatment of carotid stenosis are mostly self-controlled case series or small cohort studies with short follow-up periods. Consequently, the long-term influence of Smart nitinol stent deployment on the risk of cerebrovascular events and long-term outcomes are not known. This trial i^luminates the therapeutic benefits of the Smart nitinol stent system in a 2-year follow-up study involving a large cohort of patients with severe atherosclerotic

关 键 词：临床试验 颈动脉狭窄 支架 动脉粥样硬化 生物材料 材料相容性 Smart支架 镍钛支架系统 非随机对照试验 

分 类 号：R318[医药卫生—生物医学工程]