NCT01445613已完成不适用
CANOPY: Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,203
- 试验地点
- 1
- 主要终点
- Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)
研究概览
简要总结
The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.
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
- •Subject must be ≥ 18 years of age.
- •Subject does not have any condition that limits their anticipated survival to less than 3 years.
- •Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
- •Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-
- •Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.
- •Subject with all the following target vessel characteristics:
- •Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- •Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
- •Absence of excessive vessel tortuosity that would impede delivery of devices.
- •Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
排除标准
- •Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
- •Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.
- •Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
- •Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
研究组 & 干预措施
RX Acculink Carotid Stent System (RX Acculink)
Other
Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
干预措施: RX Acculink Carotid Stent System (RX Acculink) (Device)
结局指标
主要结局
Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)
时间窗: 0 to 365 days
Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days
时间窗: 365 days
次要结局
- Composite of Peri-procedural Death and Stroke by Symptomatic Status(30 days)
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status(365 days)
- Death and All Stroke(30 Days)
- Composite of Peri-procedural Death and Stroke by Age(30 days)
- Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age(365 days)
- Freedom From Clinically Driven Target Lesion Revascularization(365 days)
- Clinical Success(30 days)
- Freedom From Clinically Driven Target Lesion Revascularization(30 days)
- Freedom From Clinically Driven Target Lesion Revascularization(180 days)
研究者
研究点 (1)
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