Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Qualitative comparison of PCD-CT and IVI in stent evaluation
研究概览
简要总结
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).
Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Signed written informed consent
- •DES in proximal coronary vessel segments
排除标准
- •Any conditions that may interfere with the safety or efficacy of CCTA
结局指标
主要结局
Qualitative comparison of PCD-CT and IVI in stent evaluation
时间窗: Within 1 year
Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
Quantitative comparison of PCD-CT and IVI in stent evaluation
时间窗: Within 1 year
Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization
次要结局
- Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis(Within 1 year)
- Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology(Within 1 year)
- Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology(Within 1 year)
研究者
Eva Steinacher
MD
Medical University of Vienna