A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Primary Safety
研究概览
简要总结
The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)
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
- •The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.
- •≥ 18 years of age
- •Presents within 6 hours of acute MI symptoms
- •Evidence of ST elevation
- •First myocardial infarction
- •Written informed consent
排除标准
- •The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.
- •Contraindications to antiplatelet/anticoagulation therapy
- •History of blood disorders or active bleeding
- •Renal dysfunction or failure
- •Neurologic damage
- •Cardiogenic shock
- •History of cerebrovascular disease
- •History of transfusion reaction
- •Prior coronary artery bypass surgery
- •Participation in another trial with an investigational drug or device
研究组 & 干预措施
TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
干预措施: TandemHeart System (Device)
TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
干预措施: Percutaneous coronary intervention (Procedure)
PCI
Percutaneous coronary intervention
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
Primary Safety
时间窗: 30 days post-procedure
Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications
次要结局
未报告次要终点