PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 57
- 主要终点
- The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
研究概览
简要总结
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
- •Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
- •Subject (or legal representative) provides written informed consent.
排除标准
- •Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
- •Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
- •Subject has compromised blood flow to the right upper extremity.
- •Subject has access vessels with excessive tortuosity.
- •Subject has uncorrected bleeding disorders.
- •Subject is contraindicated for anticoagulant and antiplatelet therapy.
研究组 & 干预措施
TAVR with Sentinel
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
干预措施: Sentinel® Cerebral Protection System (Device)
TAVR without Sentinel
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
结局指标
主要结局
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
时间窗: <=72 hours
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
次要结局
未报告次要终点