Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events
研究概览
简要总结
In summary, the purpose of the study is to evaluate whether the Wirecath device can be used as a standard pressure wire in a safe and efficient way.
详细描述
Simultaneous measurements study (group 1) This group will be recruited and assessed in parallel with recruitment to group 2 at the discretion of the treating physician, based on the resource availability in the cath lab.
In the simultaneous measurements study group, measurements will be collected from a Wirecath® and a regular sensor-tipped pressure wire in the same position in the coronary artery at the same time (simultaneously). The regular wire to be used is the market leading Abbott PressureWire®.
By comparing the pressure measurements (Pd) from Wirecath® and from a regular sensor-tipped wire, we intend to examine if the pressure reported by the two wires deviate in any way. If a deviation exists, the hydrostatic error, caused by the height difference between the positions of Pa and Pd when using a sensor-tipped wire, will be assessed.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
- first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and
- second together with a Hexacath/Rayflow@ infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18yrs age)
- •Informed consent given
- •Patients with result from diagnostic angiography
- •Indication for coronary pressure assessment
排除标准
- •Patients with known Heparin-Induced Thrombocytopenia (HIT) or allergy to heparin.
- •Inability to tolerate Adenosine
- •Any condition, e.g. unstable health, which in the opinion of the investigator makes the patient unsuitable for inclusion (Decision documented in inclusion log).
结局指标
主要结局
Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events
时间窗: 30-60 minutes
The safety of the Wirecath@ will be assessed through the frequency and severity of all adverse events reported for study subjects after the completion of the pressure measurement and PCI. The primary endpoint will be achieved when the device has been used on enrolled patients and required measurements have been taken.
次要结局
- Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR(14 days)
- Comparison with Abbott pressure wire(30-60 minutes)