NCT02066740已完成不适用
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Medtronic Endovascular1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Absence of Stent Elongation
研究概览
简要总结
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
- •or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.
排除标准
- •Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
研究组 & 干预措施
EverFlex™ stent with Entrust™ delivery system
Experimental
干预措施: EverFlex™ stent with Entrust™ delivery system (Device)
结局指标
主要结局
Absence of Stent Elongation
时间窗: Intra operative
Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length
Successful Stent Deployment
时间窗: Procedure
Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.
次要结局
未报告次要终点
研究者
研究点 (1)
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