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中华介入放射学电子杂志

中华介入放射学电子杂志 ›› 2017, Vol. 05 ›› Issue (01) : 27 -31. doi: 10.3877/cma.j.issn.2095-5782.2017.01.008

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介入再通治疗非急性期颅内椎基底动脉闭塞的注册登记研究方案
常凯涛1, 李天晓1,†(), 贺迎坤1,†(), 王子亮1, 朱良付1, 薛绛宇1, 白卫星1, 冯光1, 冯周琴1, 韩冰莎1, 王梅云2, 白岩2, 徐志伟3, 赵婧革3, 田咏梅4, 赵晓娟5, 李桢桢1   
  1. 1. 450003　郑州大学人民医院介入科，河南省人民医院高级卒中中心
    2. 450003　郑州大学人民医院放射科
    3. 450003　郑州大学人民医院科研服务中心
    4. 450003　郑州大学公共卫生学院
    5. 450003　郑州大学人民医院超声科
  • 出版日期:2017-02-01
  • 通信作者: 李天晓, 贺迎坤
  • 基金资助:
    国家自然科学基金(81601583); 河南省重点科技攻关项目(162102310268); 河南省卫生科技攻关项目(201403191)

Registry study of the recanalization and stenting for non-acute intracranial vertebrobasilar artery occlusion

Kaitao Chang1, Tianxiao Li1,†(), Yingkun He1,†(), Ziliang Wang1, Liangfu Zhu1, Jiangyu Xue1, Weixing Bai1, Guang Feng1, Zhouqin Feng1, Bingsha Han1, Meiyun Wang2, Yan Bai2, Zhiwei Xu3, Jingge Zhao3, Yongmei Tian4, Xiaojuan Zhao5, Zhenzhen Li1   

  1. 1. Interventional Department of Zhengzhou University People’s Hospital, Cerebrovascular Center of Henan Provincial People’s Hospital
    2. Radiology Department of Zhengzhou University People’s Hospital
    3. The Center for Scientific Research of Zhengzhou University People’s Hospital
    4. College of Public Health of Zhengzhou University
    5. Ultrasound Department of Zhengzhou University People's Hospital, Zhengzhou 450003, China
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常凯涛, 李天晓, 贺迎坤, 王子亮, 朱良付, 薛绛宇, 白卫星, 冯光, 冯周琴, 韩冰莎, 王梅云, 白岩, 徐志伟, 赵婧革, 田咏梅, 赵晓娟, 李桢桢. 介入再通治疗非急性期颅内椎基底动脉闭塞的注册登记研究方案[J]. 中华介入放射学电子杂志, 2017, 05(01): 27-31.

Kaitao Chang, Tianxiao Li, Yingkun He, Ziliang Wang, Liangfu Zhu, Jiangyu Xue, Weixing Bai, Guang Feng, Zhouqin Feng, Bingsha Han, Meiyun Wang, Yan Bai, Zhiwei Xu, Jingge Zhao, Yongmei Tian, Xiaojuan Zhao, Zhenzhen Li. Registry study of the recanalization and stenting for non-acute intracranial vertebrobasilar artery occlusion[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2017, 05(01): 27-31.

目的：

评估介入再通治疗非急性期颅内椎基底动脉闭塞的可行性和初步疗效。

方法：

本研究为单中心注册登记研究，计划入组60例非急性期颅内椎基底动脉闭塞行介入再通治疗患者。主要观察指标：（1）入组12个月内的责任病变相关性卒中事件;（2）入组12个月内的责任病变相关性短暂性脑缺血发作（TIA）事件。次要观察指标：（1）成功再通率；（2）术后6个月支架再狭窄发生率；（3）所有与研究相关严重不良事件发生率；（4）入组时、出院时、入组后3个月、6个月、12个月的改良的Rankin量表（mRS）评分改变情况。安全性指标：（1）入组后30 d内所有卒中事件；（2）入组后30 d内所有死亡事件；（3）入组后30 d内所有TIA事件；（4）入组后30 d内所有脑实质出血事件。

结果：

入组开始于2013年4月，到2015年12月60例介入再通患者入组完毕并随访12个月。同时收集了55例药物保守治疗患者随访12个月内的资料。目前正在进行数据分析。主要数据包括：入组30 d内的所有卒中或死亡，12个月内的责任病变区域卒中或死亡、mRS评分变化情况。

结论：

该研究将为介入再通治疗非急性期颅内椎基底动脉闭塞可行性和有效性提供更多依据，为后期进行多中心注册登记研究提供参考。

注册：

美国临床试验注册中心ClinicalTrials.gov，注册号：NCT01632865

关键词: 介入再通, 椎基底动脉闭塞, 注册登记研究
Objective:

To evaluate the safety and efficiency of the recanalization and stenting for intracranial non-acute vertebrobasilar artery occlusion.

Methods:

60 cases of non-acute vertebrobasilar artery occlusion were collected for this study with a focus on: (1) stroke occurrence in the same territory within 12 months of enrollment, (2) TIA (transient ischemic attack) occurrence in the same territory within 12 months of enrollment. This study is also concerned about: (1) the rate of successful recanalization; (2) the percentage of patients with any in-stent stenosis within 6 months of recanalization; (3) the occurrence rate of all severe adverse events associated with the procedure; (4) the changes from baseline in mRS (modified Rankin scale) on admission and discharge, and as well as 3 months, 6 months and 12 months of this enrollment. Safety indexes: (1) stroke in any territory within 30 days of enrollment; (2) death from any cause within 30 days of enrollment; (3) TIA in any territory within 30 days of enrollment; (4) intracranial hemorrhage within 30 days of enrollment.

Results:

The enrollment began in April 2013, sixty patients with recanalization and fifty-five patients with conservative treatment were recruited by December 2015. These patients were followed up for at least 12 months. Relative data are being analyzed, which include, stroke or death within 30 days of enrollment, stroke in the same territory or death within 12 months of enrollment, the changes from baseline in mRS within 12 months of enrollment.

Conclusions:

This study provides solid and feasible evidence for application of interventional recanalization in the treatment of non-acute vertebrobasilar occlusion, and may serve as a reference for later multi-center registration.

Key words: Recanalization, Vertebrobasilar artery occlusion, Registry study
图1 研究流程图
表1 术后随访及评估内容
随访项目 入组时 术后2 d 出院时 入组后30±3 d 入组后3月±4周 入组后6月±4周 入组后12月±4周
知情同意 √ ? ? ? ? ? ?
入选/排除标准 √ ? ? ? ? ? ?
病史 √ ? ? ? ? ? ?
用药方案 √ √ √ √ √ √ √
NIHSS √ √ √ ? ? ? ?
mRS √ ? √ ? √ √ √
血常规 √ ? ? ? ? ? ?
胸片 √ ? ? ? ? ? ?
心电图 √ ? ? ? ? ? ?
CT或MRI √ ? ? ? ? √ ?
血管造影 √ ? ? ? ? √ ?
不良事件 ? √ √ √ √ √ √
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