The Embolic Protection With Reverse Flow Study of the GORE Neuro Protection System in Carotid Stenting of Subjects At High Risk for Carotid Endarterectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Composite Major Adverse Event (MAE) Rate
研究概览
简要总结
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
详细描述
The GORE Flow Reversal System, manufactured by W. L. Gore & Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence.
The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80%
- •Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation
- •At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)
排除标准
- •Recent surgical procedure within 30 days before or after the stent procedure
- •Uncontrolled sensitivity to contrast media
- •Renal Insufficiency
- •Recent evolving, acute stroke within 21 days of study evaluation
- •Myocardial infarction within 72 hours prior to stent procedure
- •History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
- •Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)
- •Angiographic Exclusion Criteria:
- •Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
- •Total occlusion of the ipsilateral carotid artery
- •Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
- •Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
- •Severe lesion calcification restricting stent deployment
- •Carotid stenosis located distal to target stenosis that is more severe than target stenosis
- •> 50% stenosis of the CCA proximal to target vessel
- •Known mobile plaque in the aortic arch
结局指标
主要结局
Composite Major Adverse Event (MAE) Rate
时间窗: Treatment through 30-day visit window
Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)
次要结局
- Flow Reversal System Technical Success(Procedure)
- Flow Reversal System Success(Procedure)
- Stent Success(Procedure)
- Clinical Success(24-48 Hours Post-Procedure)
- Patency at 30 Days(Treatment through 30-day visit window)