A Phase 4 interventional study of FFR-measurement with different pressure guidewires in Coronary Artery Disease and Myocardial Ischemia, sponsored by Lokien van Nunen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Lokien van Nunen · Phase 4, Interventional, and Diagnostic
Fractional flow reserve (FFR) is the current gold standard for correct decision making with respect to revascularization in the catheterization laboratory. FFR is measured by using a pressure guidewire equipped with a pressure sensor, positioned distal to the stenosis under investigation. A newly developed pressure wire using open wire technology has recently become commercially available. The purpose of this study is to evaluate whether the Wirecath pressure guidewire can be used as standard pressure guidewire.
The effectiveness of the device will be investigated by comparing Wirecath FFR measurements with the measurements of another regular sensor-tipped pressure guidewires during simultaneous FFR measurements in the same vessel.
FFR is a lesion-specific pressure-derived index of functional severity, defined as the maximum myocardial blood flow in the presence of an epicardial stenosis compared with the maximum flow in the hypothetical absence of the stenosis. FFR is measured by advancing a pressure guidewire into the coronary artery distal to the lesion under investigation and maintained in that position. Distal coronary pressure (Pd) and aortic pressure (Pa) are measured simultaneously while inducing steady state maximum hyperemia. FFR is defined as the lowest value of Pd/Pa achieved during maximum hyperemia. An FFR value = or \< 0.80 indicates the presence of myocardial ischemia and indicates PCI is warranted.
Existing 0.014" wires with pressure measurement capabilities have been available for more than 20 years. Improvements have been done over time, but they are still regarded as inferior to ordinary guidewires when it comes to maneuverability and general guidewire properties. This is attributed to the microelectronics that are needed to facilitate the pressure measurements in these wires. These existing wires also have issues with signal stability which is often referred to as 'drift'. Drift is an electronical phenomenon that leads to a slow progressive change in the pressure value over time. a not entirely reliable signal quality.
A relatively new pressure guidewire, Wirecath, is an equivalent device to the currently commercially available pressure guidewires. In comparative bench tests it has shown very good maneuverability. Moreover due to the 'open wire' technology (and thus lack of microelectronics throughout the wire), the Wirecath has very stable signal properties and is, according to physical law and bench testing, immune against a hydrostatic error and less affected by drifting of the signal, which are limitations with current pressure guidewires.
This study is designed to examine and compare the pressure measurements of two commercially available pressure guidewires (Abbott and Cavis Technologies) by simultaneously measuring FFR in the same coronary artery with two different pressure guidewires.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Lokien van Nunen is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients will undergo simultaneous FFR measurements with the Wirecath and PressureWire X simultaneously.
Device: FFR-measurement with different pressure guidewires
Measuring FFR with different pressure guidewires
FFR
To compare the pressure signals measured by the different available pressure guidewires, specifically the FFR value
Time frame: During catheterization
Hydrostatic error
To assess the occurrence of hydrostatic errors when using sensor-tipped wires
Time frame: During catheterization
Drift
To assess the occurrence of drift between the different pressure guidewires
Time frame: During catheterization
Signal quality
To assess signal quality and stability between the different pressure guidewires
Time frame: During catheterization
Maneuverability
To assess maneuverability and handling of the different pressure guidewires
Time frame: During catheterization
Plan to share: No — There is no plan to make individual (non-anonymized) participant data available to others.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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