Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
研究概览
简要总结
The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable scaffolds.
详细描述
Standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with contrast is used. X-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable scaffolds are visualized poorly .
Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave, Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two systems are similar and are interpreted the same way.
The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with same characteristics by the two systems.
Same segment scans by the two systems will be systematically compared and reported.
Differences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions.
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
- •Indication for intervention with PCI on the right or left coronary artery
- •Age >18 years
- •Must be able to give written informed consent
排除标准
- •Expected life span of less than one year
- •Pregnancy or possible pregnancy
- •Cardiogenic shock
- •Especially tortuous vessels
- •Renal impairment (creatinine> 100 micromoles / L)
结局指标
主要结局
Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
时间窗: Baseline
Characteristics of lipid plaque (signal intensities under the fibrous cap)
时间窗: Baseline
Characteristics of fibrous tissue (maximum scan penetrance)
时间窗: Baseline
Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images
时间窗: Baseline
Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)
时间窗: Baseline
Characteristics of vessel dissection (exploratory)
时间窗: Baseline
Characteristics of the fibrous cap (minimum thickness)
时间窗: Baseline
次要结局
- Detection of stent struts(Baseline)
研究者
Niels Ramsing Holm
Doctor
Aarhus University Hospital Skejby