A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Late loss in lumen diameter in follow-up ≥50%
研究概览
简要总结
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
详细描述
The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.
The main aim of this study is to observe the following details:
- Late loss in lumen diameter in follow-up ≥50%
- Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
- Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.
- •70% to 99% stenosis of vertebral artery ostium.
排除标准
- •etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium
结局指标
主要结局
Late loss in lumen diameter in follow-up ≥50%
时间窗: 1 year
Late loss in lumen diameter in follow-up ≥50%
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
时间窗: 12 months
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
时间窗: 30 days
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
次要结局
- brain, gastrointestinal and urinary system bleeding in 12 months follow-up(12 months)