PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,501
- 试验地点
- 52
- 主要终点
- Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
研究概览
简要总结
To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age
- •Patient must sign informed consent form
- •Patient has received at least one Promus PREMIER stent
- •Patient self-identifies as one or more of the following:
- •Black of African Heritage
- •Hispanic/Latino
- •American Indian or Alaska native
排除标准
- •Not applicable
结局指标
主要结局
Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
次要结局
- Death(Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months)
- Target Vessel Revascularization (TVR)(Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months)
- Myocardial Infarction (MI)(Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months)