The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 12
- 主要终点
- The incidence of study device or study procedure adverse effect or event
研究概览
简要总结
First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Major Inclusion Criteria:
- •Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention.
- •Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures
- •Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors
- •Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours
排除标准
- •Unconsciousness
- •Previous bypass graft surgery
- •Contraindication to CMRI
- •Recent or current major bleeding within 30 days prior to intervention
- •Recent major surgery within 30 days prior to intervention
- •End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant
- •Transient ischemic attack or stroke within 30 days prior to intervention
- •Pregnant or females of childbearing potential
结局指标
主要结局
The incidence of study device or study procedure adverse effect or event
时间窗: up to 30 days
Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. To assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
次要结局
- Diagnostic Success(0 days)
- Therapeutic Success(0 days)