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

doi:10.3877/cma.j.issn.2095-5782.2016.02.012

Chinese Journal of Interventional Radiology(Electronic Edition) ›› 2016, Vol. 04 ›› Issue (02): 109-114. doi: 10.3877/cma.j.issn.2095-5782.2016.02.012

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

Yingkun He¹, Tianxiao Li¹^,^†(), Weixing Bai¹, Liangfu Zhu¹, Ziliang Wang¹, Jiangyu Xue¹, Guang Feng¹, Zhouqin Feng¹, Meiyun Wang², Li Li¹, Zhaoshuo Li¹, Tongyuan Zhao¹, Bin Xu¹, You Zhang³, Yongmei Tian⁴, Yan Bai², Xiaojuan Zhao⁵, Xiaodong Liang¹, Qiuji Shao¹, Kaitao Chang¹, ZhenZhen Li¹

^1. Interventional Department of Zhengzhou University People’s Hospital and Cerebrovascular Center of Henan Provincial People’s Hospital
^2. Radiology Department of Zhengzhou University People’s Hospital
^3. Epidemiology Center of Zhengzhou University People’s Hospital
^4. Ultrasound Department of Henan Provincial People’s Hospital
^5. Ultrasound Department of Zhengzhou University People's Hospital, Zhengzhou 450003, China

Received:2016-04-20 Online:2016-05-01 Published:2016-05-01
Contact: Tianxiao Li
About author:
Corresponding author: Li Tianxiao, Email: dr.litianxiao@vip.163.com

Abstract

Abstract:

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 attack, 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.

Key words: Vertebral artery stenosis, Drug-eluting stent, Bare metal stent, Randomized controlled trial

Yingkun He, Tianxiao Li, Weixing Bai, Liangfu Zhu, Ziliang Wang, Jiangyu Xue, Guang Feng, Zhouqin Feng, Meiyun Wang, Li Li, Zhaoshuo Li, Tongyuan Zhao, Bin Xu, You Zhang, Yongmei Tian, Yan Bai, Xiaojuan Zhao, Xiaodong Liang, Qiuji Shao, Kaitao Chang, ZhenZhen Li. Cerebrovascular drug-eluting stents verse bare metal stents in the treatment of vertebral artery stenosis[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2016, 04(02): 109-114.

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Figures/Tables 4

References 13

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