Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire (MRWIREPMCF)
研究概览
详细说明
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.
The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
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
描述
Inclusion Criteria:
- patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
- patients with body weight of > 40 kg in which the introduction of an introducer of > 5 French is possible.
- subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.
Exclusion Criteria:
- major surgery in the last 42 days
- history of irreversible bleeding disorder
- contraindication to cardiac magnetic resonance
- Contraindications to guidewire procedures, such as evidence of active infection
- women of child-bearing potential who cannot provide a negative pregnancy test
- chronic total occlusion.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 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 |
---|---|
其他:pressure gradient measurement
Diagnostic procedure to measure pressure gradient in series of patients.
Focus is on safety and absence of adverse events
|
A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.
其他名称:
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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 |
---|---|---|
Procedural success
大体时间:Up to 30 days after procedure
|
procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure
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Up to 30 days after procedure
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合作者和调查者
出版物和有用的链接
一般刊物
- Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. First magnetic resonance imaging-guided aortic stenting and cava filter placement using a polyetheretherketone-based magnetic resonance imaging-compatible guidewire in swine: proof of concept. Cardiovasc Intervent Radiol. 2009 May;32(3):514-21. doi: 10.1007/s00270-008-9483-5. Epub 2008 Dec 30.
- Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. MR-compatible polyetheretherketone-based guide wire assisting MR-guided stenting of iliac and supraaortic arteries in swine: feasibility study. Minim Invasive Ther Allied Technol. 2009;18(3):181-8. doi: 10.1080/13645700902921971.
- Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire. Invest Radiol. 2009 Apr;44(4):234-41. doi: 10.1097/RLI.0b013e31819b00f1.
研究记录日期
研究主要日期
学习开始
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 (估计)
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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