Self-Centering Guide Catheter Feasibility Study
2018年8月27日 更新者：Boston Scientific Corporation
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
研究概览
详细说明
A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter.
All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study.
The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 110年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.
Exclusion Criteria:
- Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
- Subject has a pre-existing prosthetic aortic valve.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Self-Centering Guide Catheter
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
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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 |
|---|---|---|
|
Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle
大体时间：Through study completion, up to 72 hours post-procedure
|
This outcome will be assessed via physician determination and will be recorded in the case report form.
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Through study completion, up to 72 hours post-procedure
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve
大体时间：Through study completion, up to 72 hours post-procedure
|
Through study completion, up to 72 hours post-procedure
|
|
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Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body
大体时间：Through study completion, up to 72 hours post-procedure
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Through study completion, up to 72 hours post-procedure
|
|
|
Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire
大体时间：Through study completion, up to 72 hours post-procedure
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Through study completion, up to 72 hours post-procedure
|
|
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Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System
大体时间：Through study completion, up to 72 hours post-procedure
|
The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.
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Through study completion, up to 72 hours post-procedure
|
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Number of Self-Centering Guide Catheters With Device Success
大体时间：Through study completion, up to 72 hours post-procedure
|
Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system.
This outcome will be assessed via physician determination and will be recorded in the case report form.
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Through study completion, up to 72 hours post-procedure
|
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Number of Participants With Stroke
大体时间：72 hours post-procedure
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72 hours post-procedure
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|
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Number of Participants With Cardiac Tamponade
大体时间：72 hours post-procedure
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72 hours post-procedure
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|
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Death, All-cause, Cardiovascular, and Non-cardiovascular
大体时间：72 hours post-procedure
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72 hours post-procedure
|
|
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Any Device-related Adverse Event
大体时间：72 hours post-procedure
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72 hours post-procedure
|
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Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
大体时间：72 hours post-procedure
|
72 hours post-procedure
|
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Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors
大体时间：72 hours post-procedure
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All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form
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72 hours post-procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rajiv Gulati, MD, PhD、Mayo Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年5月12日
初级完成 (实际的)
2016年10月6日
研究完成 (实际的)
2016年10月6日
研究注册日期
首次提交
2015年12月17日
首先提交符合 QC 标准的
2015年12月21日
首次发布 (估计)
2015年12月24日
研究记录更新
最后更新发布 (实际的)
2018年8月29日
上次提交的符合 QC 标准的更新
2018年8月27日
最后验证
2018年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.