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临床试验/ACTRN12608000581369
ACTRN12608000581369进行中(未招募)未知

A Prospective, Multicentre Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element) in the Treatment of Patients with a single De Novo Atherosclerotic Lesion

Boston Scientific Corporation0 个研究点目标入组 100 人开始时间: 2008年11月19日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
100

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 doucmented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris
  • 3. Patient is acceptable candidate for CABG
  • 4. Patient has left ventricular ejection fraction 0f >30%
  • 5. Target lesion must be de novo and located within native coronary artery with diameter >2.25mm and <4.25mm
  • 6. Target lesion must be <34mm in length
  • 7. Target lesion must be in a major coronary artery 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 30 days of 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

研究者

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