NL-OMON49631撤回不适用
PROTECTED TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement - S2453 PROTECTED TAVR
Boston Scientific Cooperation International0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All eligible subjects should be approached for participation in the trial.
- •Subjects who meet all of the following criteria will be evaluated for
- •enrollment in this trial, provided no exclusion criterion
- •(below) is met.
- •IC1. Subject has documented aortic valve stenosis and is treated with an
- •approved TAVR device via transfemoral access.
- •IC2. 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.
- •IC3. Subject (or legal representative) provides written informed consent.
排除标准
- •Subjects who meet any one of the following criteria (listed as
- •contraindications in the Sentinel® Cerebral Protection System IFU) will be
- •excluded from this clinical trial.
- •EC1. Subject has arterial stenosis >70% in either the left common carotid
- •artery or the brachiocephalic artery.
- •EC2. 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.
- •EC3. Subject has compromised blood flow to the right upper extremity.
- •EC4. Subject has access vessels with excessive tortuosity.
- •EC5. Subject has uncorrected bleeding disorders.
- •EC6. Subject is contraindicated for anticoagulant and antiplatelet
- •Note 4: Use of general anesthesia during TAVR may affect neurocognitive
- •function shortly after the procedure. While not an exclusion criterion, it is
- •recommended that general anesthesia not be
- •used if possible.
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