NCT00619775已完成3 期
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Medtronic Endovascular62 个研究点 分布在 1 个国家目标入组 419 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 419
- 试验地点
- 62
- 主要终点
- Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
研究概览
简要总结
Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.
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
- •18 years and above
- •informed consent
- •for female subjects, not pregnant or planning on becoming pregnant
- •meet protocol defined anatomical or clinical high risk criteria
排除标准
- •participation in another clincial study which may affect either the pre-procedure or follow-up results
- •prior stenting of the ipsilateral carotid artery
- •life expectancy less than twelve months
- •known allergy or intolerance of study medications or device materials
- •must not meet general or angiographic exclusion criteria as defined in the protocol
结局指标
主要结局
Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
时间窗: 30 days and one year
次要结局
- Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation(30 days and one year)
- Target vessel revascularization(one year)
- Target lesion revascularization(one year)
- Primary patency at one year (<70% stenosis as measured by duplex scan)(one year)
- Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%)(at implant)
研究者
研究点 (62)
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