NCT01901874已完成不适用
GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy
W.L.Gore & Associates4 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 4
- 主要终点
- Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
研究概览
简要总结
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
详细描述
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.
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
- •Patient is at least 18 years old at informed consent
- •Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
- •Patient is willing to provide written informed consent prior to enrollment in study.
- •Patient is either:
- •Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR
- •Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology
- •Patient must be considered high risk for adverse events during carotid endarterectomy
- •Note: Additional inclusion criteria may apply
排除标准
- •Patient has life expectancy of less than one year.
- •Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke.
- •Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months).
- •Patient has had an acute myocardial infarction within 72 hours prior to the index procedure.
- •Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments.
- •Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure.
- •Note: Additional exclusion criteria may apply
结局指标
主要结局
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
时间窗: 365 days
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
次要结局
- Number of Participants Who Achieved Procedure Success(Procedural)
- 30-Day MAE - Myocardial Infarction(30 days)
- Number of Participants Who Experienced MAE at 30 Days(30 days)
- Target Lesion Revascularization(365 days)
- Number of Participants Who Achieved Stent Technical Success(Procedural)
- In-Stent Restenosis(365 days)
- 30-Day MAE - Death(30 days)
- Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success(Procedural)
- 30-Day MAE - Stroke(30 days)
研究者
研究点 (4)
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