NCT03488199已完成不适用
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月11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
- 100
- 试验地点
- 1
- 主要终点
- determination of ischemic lesions
研究概览
简要总结
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards
详细描述
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed.
Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
- •More than 6-month life expectancy
- •Suitable clinical conditions for performing DW-MRI
- •Written Informed consent approved by the Ethics Committee
- •Subject agrees to all required follow-up procedures and visits
排除标准
- •Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
- •Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
- •Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
- •Recent evolving acute stroke within 30-days of study evaluation
- •Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal)
- •Female patients of childbearing potential or known to be pregnant
- •Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
- •Patient on VKA or new oral anticoagulants
结局指标
主要结局
determination of ischemic lesions
时间窗: at 48 hours
New DW-MRI lesions post procedural (48 hours)
次要结局
未报告次要终点
研究者
研究点 (1)
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