NCT01694368已完成不适用
Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- MACCE
研究概览
简要总结
To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention
详细描述
This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subject is at > 18 years of age
- •Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography
- •Subject is willing and able to provide informed written consent
- •Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment
- •Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention
排除标准
- •Subject is pregnant or suspected to be pregnant
- •Subject is unable to provide informed consent
- •Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS
结局指标
主要结局
MACCE
时间窗: 5 year
次要结局
未报告次要终点
研究者
Ryan Madder, MD
Physician
Spectrum Health Hospitals
研究点 (1)
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