Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Vascular complications at the arterial access site
研究概览
简要总结
FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.
First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Informed consent about the study
- •Elective PCI with following indications:
- •Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI
- •patient eligible for coronary angiography and both radial and femoral PCI
- •requirement of using a vascular closure device (without contraindications)
排除标准
- •inability to understand and sign the informed consent term
- •pregnancy
- •less 18 years of age
- •single diagnostic coronary angiography
- •active or high bleeding risk (thrombocytopenia <50,000/µl)
- •femoral approach and PCI without using a vascular closure device
- •other conditions hampering involvement in the study
结局指标
主要结局
Vascular complications at the arterial access site
时间窗: 30 days
Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Adverse cardiac events
时间窗: 12 months
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
次要结局
未报告次要终点
研究者
Michael Behnes
Sub-PI
Universitätsmedizin Mannheim