Dynamic Coronary Roadmap for Contrast Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 6
- 主要终点
- Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
研究概览
简要总结
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries.
This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
详细描述
Primary objective:
• To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Secondary objective:
• To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subject is undergoing Percutaneous Coronary Intervention (PCI) with a degree of complexity that anticipates the need for more than 25ml of iodinated contrast volume
- •Subject has signed informed consent
- •Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
排除标准
- •Subject undergoing emergency Percutaneous Coronary Intervention (PCI)
- •Subject with ST-segment Elevation Myocardial Infarction (STEMI)
- •Subject with Chronic Total Occlusion (CTO)
- •Subject undergoing PCI for isolated ostial disease of Left Main Coronary Artery (LMCA) or Right Coronary Artery (RCA)
- •Subject undergoing Percutaneous Coronary Intervention (PCI) with Optical Coherence Tomography (OCT) support
- •Subject undergoing Percutaneous Coronary Intervention (PCI) with rotational or orbital atherectomy
- •Subject with Chronic Kidney Disease (CKD) stage V (estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73 m^2)
- •Subject with contrast allergy that cannot be adequately pre-medicated
- •Subject participates in a potentially confounding drug or device trial during the course of the study.
- •Subject is under 18 years of age, or pregnant woman, or breast feeding woman, or meets an exclusion criteria according to national law
研究组 & 干预措施
Dynamic Coronary Roadmap group
Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap.
干预措施: Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap (Device)
Control group
Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap.
干预措施: Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap (Device)
结局指标
主要结局
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
时间窗: During Percutaneous Coronary Intervention (PCI) procedure
Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram).
次要结局
- Number of Angiograms(During Percutaneous Coronary Intervention (PCI) procedure)