ACTRN12608000373370招募中不适用
A Pilot Study Evaluating the Safety and Performance of the IDEAL TM Bioabsorbable Coronary Stent Platform Eluting Sirolimus for the Treatment of Patients with Coronary Artery Disease
Bioabsorbable Therapuetics, LTD0 个研究点目标入组 60 人开始时间: 2008年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. The patient has documented evidence of ischemic heart disease or a positive functional study.
- •2. The patient has a single de novo target lesion in a native coronary artery.
- •4. Target lesion stenosis is greater than 50% and less than 100%.
排除标准
- •1. The patient has a restenotic target lesion.
- •2. The patient has a lesion involving a bifurcation > 2mm in diameter and ostial lesion > 40% stenosis or side branch requiring dilatation.
- •3. Target vessel contains visible thrombus.
- •4. The patient has an inability to tolerate, adverse reaction, or contraindication to taking study medications or device materials.
- •5. The target lesion is a total occlusion.
- •6. Myocardial Infarction (MI) within 48 hours.
- •7. The patient has more than one lesion requiring treatment in the target vessel.
- •8. The patient has one or more non-target lesion requiring treatment.
研究者
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