AVERT™ Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 578
- 试验地点
- 77
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).
详细描述
The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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 subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
- •The subject has documented chronic kidney disease (CKD)
排除标准
- •Subject is in acute renal failure
- •Assessment of ventricular function that cannot be accomplished without the use of the CM.
- •Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.
- •Subject is unable to undergo peri-procedural hydration.
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 3-5 days
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
时间窗: 30 days
Analyze the incidence of device related serious adverse events within the treatment arm.
次要结局
- Secondary Endpoint 1-(30 Days)
- Secondary Endpoint 3- Change in Kidney Function.(3-5 days)
- Secondary Endpoint 2- Comparison of Serious Adverse Events.(30 Days)