NCT01833052Unknown不适用
CLaret Embolic Protection ANd TAVI - Trial
University of Leipzig2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate and Size of Cerebral Embolism
研究概览
简要总结
This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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 scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system.
排除标准
- •Patient is unsuitable for TAVI
- •Prior Stroke or TIA in the last 12 month
- •Carotic stenosis >70%
- •Relevant stenosis of the brachiocephalic trunc or the right subclavian artery
- •Expected Non-compliance for follow-ups
- •Pregnancy
- •Patient is already recruited for another study
结局指标
主要结局
Rate and Size of Cerebral Embolism
时间窗: 2 days after Intervention
Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI).
次要结局
未报告次要终点
研究者
Prof. Dr. med. A. Linke
Prof. Dr. med. A. Linke
University of Leipzig
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ DeviceCerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable ValvesNCT02895737Deutsches Herzzentrum Muenchen328
已完成
不适用
A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill PatientsHemorrhageVenous ThromboembolismNCT02213978Beijing Chao Yang Hospital1,114
已完成
不适用
Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous ThromboembolismVenous ThromboembolismVenous ThrombosisNCT03044574Pirogov Russian National Research Medical University407
Unknown
不适用
CaveoVasc Thrombolysis Protection System, Access Protection StudyThrombolysisNCT03166059CaveoMed GmbH20
已完成
不适用
The PROTEMBO TrialSevere Aortic Valve StenosisNCT05873816Protembis GmbH284