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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Ⅰ~Ⅱ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(Maurora Stent),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 d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作、卒中及死亡情况,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9月,到2015年9月40例患者入组完毕,随机分组后随访12个月内的资料,主要包括手术相关并发症、相关性短暂性脑缺血发作、卒中及死亡情况,同时还包括非手术相关性不良事件的发生情况。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。
Objective: To evaluate the safety and efficacy of a novel stent for treatment of vertebral artery stenosis. Methods: This study was a single center randomized controlled phase Ⅰ ~ Ⅱ clinical study. 40 patients with severe stenosis of vertebral artery (stenosis≥70%) were enrolled in the study. The patients were assigned to experimental group and control group according to 1: 1. The experimental group used a new type of brain tumor drug-eluting stent system (Maurora Stent), while the control group used the cerebrovascular-specific bare metal ball expanded stent (Apollo). MAIN OUTCOME MEASURES: In-stent restenosis at 6 months and surgery-related complications within 30 days postoperatively; Secondary outcome measures were ipsilateral transient ischemic attack within 12 months after surgery, stroke And deaths, as well as all adverse events and serious adverse events. Results: The study was started in September 2014 and ended in September 2015. Forty patients were enrolled and randomized to follow up for 12 months. The main data included surgery-related complications, related transient ischemic attacks , Stroke and death, as well as the occurrence of non-surgical-related adverse events. Conclusion: This study will provide a clinical basis for the clinical application of drug-eluting stent in cerebrovascular disease and provide a reference for the later phase Ⅲ multicenter randomized controlled study.