Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 35
Summary
- Conditions
- Coronary Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Results from simultaneous measurements with two wires will be graphically showed using the Bland-Altman plot and reported in terms of intraclass correlation coefficient (ICC). Also, whether a theoretical correction for the expected hydrostatic pressure error (0.77 mmHg per cm height difference) at the distal pressure measurement site (Pd) accounts for the difference in FFR during simultaneous measurements will be explored, and a corrected ICC reported. A two-sided p-value of <0.05 will be considered to be significant, when applicable. The Pearson's correlation coefficient will be also calculated considering the Wirecath FFR value in comparison to the FFR value made with the regular wire with and without correction for hydrostatic error. For the CFR values, the Pearson's correlation coefficient will be used to determine the relation between the bolus-thermo CFR, absolute-flow CFR, Echo CFR and the pressure-derived CFR in the LAD.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
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 fr...
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). Wirecath will be used for PCI when indicated and performance documented by follow-up questions to the users. Regular study group (group 2) In the regular use study group, the Wirecath® is to be used as a regular pressure measurement tool, replacing the regularly used pressure wire. Pressure measurement results will be collected. Wirecath® will be used for PCI when indicated and performance documented by follow-up questions to the users. 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). Echocardiography-CFR group (group 3) Patients from group 1 and group 2 that have undergone Bolus-thermo and Absolute-flow CFR measurements, will be recruited to group 3. In this group echocardiography-CFR (Echo CFR) will be measured within 14 days. The echocardiography is performed according to the standard procedure of the hospital. The correlation between the methods will be investigated.
Tracking Information
- NCT #
- NCT04776577
- Collaborators
- Cavis Technologies AB
- Investigators
- Principal Investigator: Oskar Angerås, MD PhD Sahlgrenska University Hospital, Gothenburg, Sweden
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