Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hemodynamic Compromise (HC)
研究概览
简要总结
In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.
The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).
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
- •Signed Informed Consent
- •Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
排除标准
- •Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
- •History of recent (within 1 month) stroke or TIA
- •Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors
结局指标
主要结局
Hemodynamic Compromise (HC)
时间窗: 30 days.
Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure
Safety & feasibility
时间窗: 30 days
Accurate classification of patients into the respective group defined by the necessity of upgrade
次要结局
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(30 days)
- Adverse events(30 days)
研究者
Fadi Al-Rashid
Principal Investigator
University Hospital, Essen