NCT01343667已完成不适用
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
W.L.Gore & Associates77 个研究点 分布在 1 个国家目标入组 1,397 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,397
- 试验地点
- 77
- 主要终点
- Major Adverse Events (MAE)
研究概览
简要总结
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
详细描述
Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure.
This study is not designed to compare study endpoints between the two treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient, or patient's legal representative, is able and willing to provide informed consent.
- •Patient must be at least 18 years of age or older.
- •Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU.
排除标准
- •Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected
- •If the patient is contraindicated for both arms (devices) they may not be enrolled.
结局指标
主要结局
Major Adverse Events (MAE)
时间窗: Onset from start of index procedure to 30-day follow-up assessment
Major Adverse Events include death, stroke and myocardial infarction
次要结局
未报告次要终点
研究者
研究点 (77)
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