Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) (RE-ACCESS)
Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
研究概览
详细说明
Single-center, prospective, pilot study. Aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with pre-procedural computed tomography assessment available.
The possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal comparator.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Catania、意大利、95123
- Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices
- Availability of preprocedural aortic root evaluation by computed tomography angiography scans
Exclusion Criteria:
- TAVR in degenerated bioprostheses
- Known ostial chronic total occlusion
- Transcatheter valve not deployed in its anatomical position
- Patients with hemodynamic instability during the procedure
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
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Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
大体时间：5 minutes
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Angiographic assessment of coronary ostia selective cannulation after TAVR
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5 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR
大体时间：5 minutes
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Aortic root CTA measurements and prosthesis implantation-related factors associated with inability to selectively cannulate coronary ostia after TAVR at multivariate regression analysis
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5 minutes
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合作者和调查者
调查人员
- 首席研究员：Marco Barbanti, MD、University of Catania
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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