脑血管药物洗脱支架与金属裸支架治疗椎动脉狭窄的临床随机对照研究方案

Cerebrovascular drug-eluting stents verse bare metal stents in the treatment of vertebral artery stenosis

目的：评估新型脑血管药物洗脱支架治疗椎动脉狭窄的安全性和初步疗效方法：本研究为上市前ⅠⅡ期单中心随机对照研究，计划入组40例椎动脉重度狭窄患者（狭窄度≥70%），按1：1分配到实验组和对照组。实验组使用新型脑血管药物洗脱支架系统（MauroraStent），对照组使用脑血管专用裸金属球扩式支架（Apollo）。主要观察指标是：术后6个月的支架内再狭窄和术后30内的手术相关并发症；次要观察指标为：术后12个月内同侧性短暂性脑缺血发、卒中死亡，以及所有不良事件和严重不良事件发生情况。结果：研究入组开始于2014年月，到2015年9月40例患者入组完毕，随机后12个月内的资料，。结论：该试验将为脑血管药物洗脱支架的临床应用提供临床依据，为后期进行Ⅲ期多中心随机对照研究提供参考。注册：世界卫生组织国际临床试验注册平台-中国临床试验注册中心ChiCTR-IIR-16009115。

Objective： To evaluate the safety and efficacy of the new drug-eluting stent in the treatment of vertebral artery stenosis.Methods： This study was a single-center, randomized controlled trial of pre-marketing Ⅰ-Ⅱ stage. 40 patients with the severe stenosis of the vertebral artery （≥70% stenosis） were enrolled in this study. All the patients were divided into experimental group and control group according to the ratio of 1： 1. In the experimental group, a new cerebrovascular drug-eluting stent system （MauroraStent） was used. In the control group, a bare metal stent （Apollo） was used. The primary outcomes were surgical-related complications within 30 days and in-stent restenosis on the 6 months after surgery. Secondary outcomes were as follows ： ipsilateral transient ischemic development, stroke, death, As well as all adverse events and serious adverse events. Results： Enrollment began in September 2014, and was done in september 2015 with 40 patients enrolled into the study. 12-month data including ipsilateral complication, transient ischemic attack, stroke and all adverse events were collected. Data entry and analysis are ongoing. Conclusions： This study will provide a clinical basis for the clinical application of drug-eluting stent in cerebrovascular disease, and provide reference for the later phase Ⅲ multicenter randomized controlled study