Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 138
- 主要终点
- Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
研究概览
简要总结
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
详细描述
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have had a cryptogenic stroke within the last 270 days
- •Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
- •Subjects willing to participate in follow-up visits
排除标准
- •Subjects with intracardiac thrombus or tumor
- •Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- •Subjects with left ventricular aneurysm or akinesis
- •Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- •Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- •Subjects with contraindication to aspirin or Clopidogrel therapy
- •Pregnant or desire to become pregnant within the next year
研究组 & 干预措施
Device
AMPLATZER PFO Occluder
干预措施: AMPLATZER PFO Occluder (Device)
Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
干预措施: Standard of Care - Medical Management (Other)
结局指标
主要结局
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
时间窗: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
次要结局
- Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group(6 months)