NCT01670318Unknown不适用
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
The PCI Guideline Research Society76 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 76
- 主要终点
- Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
研究概览
简要总结
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
- •Male or non-pregnant female
- •Key lesion inclusion criteria as follows
- •Multi-vessel diseases
- •Long lesion (lesion length >30mm by visual estimation)
- •Small vessel disease (reference diameter <2.5mm by visual estimation)
- •Bifurcation lesion
- •Ostial lesion
- •Calcified lesion
- •Protected or non-protected left main trunk disease
- •Chronic total occlusion
- •In stent restenosis of bare metal stent or everolimus-eluting stent
排除标准
- •Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
- •Serum creatinine level >3.0 mg/dL
- •Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
结局指标
主要结局
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
时间窗: 12 month
次要结局
- Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site(In hospital)
- Target lesion revascularization(12 month)
- Target vessel revascularization(12 month)
- Myocardial infarction(24 month)
- Cardiac death(24 month)
- Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization(24 month)
- Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)(24 month)
研究者
研究点 (76)
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