Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,001
- 试验地点
- 1
- 主要终点
- Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
研究概览
简要总结
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
详细描述
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving Promus Element stents
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy <1 year
- •Patients with cardiogenic shock
结局指标
主要结局
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
时间窗: 12 months post stenting procedure
次要结局
- Myocardial infarction(yearly up to 5 years)
- Death (all-cause and cardiac)(30 days)
- Target Vessel Revascularization(yearly up to 5 years)
- Composite of cardiac death or MI(yearly up to 5 years)
- Stent thrombosis(yearly up to 5 years)
- Composite of death or MI(yearly up to 5 years)
- Death (all cause and cardiac)(yearly up to 5 years)
- Target lesion revascularization(yearly up to 5 years)
- Procedural success(defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)(3 days in average)
研究者
Seung-Jung Park
MD,PhD
CardioVascular Research Foundation, Korea