GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO) - The Gore REDUCE Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 664
- 试验地点
- 2
- 主要终点
- Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
研究概览
简要总结
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.
A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.
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
- Single (Outcomes Assessor)
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
- •Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
- •Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
- •Absence of an identifiable source of thromboembolism in the systemic circulation
- •No evidence of a hypercoagulable state
- •Note: Additional Inclusion Criteria may apply
排除标准
- •Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
- •Previous Myocardial Infarction
- •Active infection that cannot be treated successfully prior to randomization
- •Sensitivity or contraindication to all proposed medical treatments
- •Pregnancy or intent on becoming pregnant through 24-months after randomization
- •Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be > 18mm
- •Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
- •Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
- •Note: Additional Exclusion Criteria may apply
研究组 & 干预措施
Medical Management
Antiplatelet medical therapy alone
干预措施: Antiplatelet Medical Therapy (Drug)
Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
干预措施: Septal Occluder Device (Device)
Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
干预措施: Antiplatelet Medical Therapy (Drug)
结局指标
主要结局
Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
时间窗: 24 months
A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)
时间窗: 24 months
Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days. An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm.
次要结局
- Number of Subjects With Effective Closure in Test (Device) Arm(24 months)
- Number of Subjects With Study-related Serious Adverse Events(24 months)