NCT02501148已完成不适用
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Device-related MAE
研究概览
简要总结
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA)
- •Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography
- •Target lesion can be covered by a single stent of no more than 40 mm in length
- •Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm
- •Sufficient landing zone required for successful deployment of integrated embolic protection filter
- •Willing to comply with all follow-up required study visits
- •Provision of written informed consent before index procedure
排除标准
- •Life expectancy of less than one year
- •An evolving, acute or recent stroke within 14 days of study evaluation
- •Acute myocardial infarction within 72 hours before procedure
- •Known sensitivity to contrast media that cannot be adequately controlled with pre-medication
- •Subject has a total occlusion of target carotid artery
- •Subject has a previously place stent in ipsilateral carotid artery
- •Severe circumferential lesion calcification that may restrict full deployment of carotid stent
- •Presence of filling defect or thrombus in target vessel
- •Presence of "string sign" of target vessel
- •Carotid (intracranial) stenosis located distal to target lesion
- •Greater than 50% stenosis of common carotid artery proximal to target lesion.
- •Known mobile plaque in aortic arch
结局指标
主要结局
Device-related MAE
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (5)
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