EXCEL Clinical Trial (Universal Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.
研究概览
简要总结
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.
详细描述
Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.
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
- •Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
排除标准
- 未提供
结局指标
主要结局
This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.
时间窗: At the time of enrollment into the study
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns. There are no follow-up time points for this study.
次要结局
未报告次要终点