NCT02363894已完成不适用
Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study
Medtronic Endovascular0 个研究点目标入组 53 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- Major Adverse Event Rate
研究概览
简要总结
The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Was a subject in DEFINITIVE AR I
- •Is able and willing to provide written informated consent prior to study specific data collection.
排除标准
- •Withdrew consent in DEFINITIVE AR I.
- •Was reported dead during DEFINITIVE AR I.
结局指标
主要结局
Major Adverse Event Rate
时间窗: 2 years
次要结局
未报告次要终点
研究者
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