ACTRN12609000724279招募中未知
A Prospective, Multicentre Trial to assess the safety & effectiveness of anEverolimus-Eluting Coronary Stent System(PROMUS Element) for the Treatment of a Single De Novo Coronary Artery Long Lesion (24 - 34mm in length)
Boston Scientific Pty Ltd0 个研究点目标入组 102 人开始时间: 2009年8月24日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patient is eligible for percutaneous coronary intervention (PCI)
- •2. Patient has documented stable angina
- •pectoris, or documented silent ischaemia, or
- •unstable angina pectoris
- •3. Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG)
- •4. Patient has left ventricular ejection fraction of >30%
- •5. Target lesion must be de novo and located within native coronary artery with diameter 2.5mm to 4.25mm
- •6. Target lesion must be 24mm to 34mm in length
- •7. Target lesion must be in a major coronaryartery or branch with visually estimated stenosis >50% and <100%
排除标准
- •1. Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI)
- •2. Patient has known diagnosis of recent MI
- •(within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure
- •3. Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure
- •4. Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome
- •5. Females who are pregant, nursing/lactating or planning to procreate within 12 months of the index procedure
研究者
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