NCT05077657已完成不适用
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 11
- 主要终点
- Incidence of access site related BARC type III or V bleeding
研究概览
简要总结
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).
详细描述
To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥18 years of age
- •Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
- •The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.
排除标准
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- •Active bleeding
- •Incapacity to access safely femoral artery or femoral vein
- •Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
- •Anemia (Hgb <9 g/dL), thrombocytopenia (Plt <50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Active infection not controlled with antibiotic therapy
- •Currently pregnant or women of child-bearing potential without documented negative pregnancy test
- •Estimated life expectancy < 24 hours
- •Patient is in cardiogenic shock at the time of enrollment
结局指标
主要结局
Incidence of access site related BARC type III or V bleeding
时间窗: Within 24 hours
次要结局
- Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator(Within 24 hours)
- Incidence of all BARC type III or V bleeding(Within 24 hours)
研究者
研究点 (11)
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