Pressure Guidewire Comparison

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Piezo-electric Versus Open Wire Pressure Guidewires for FFR Measurements: Comparison of Two Commercially Available Pressure Wires

Conditions
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Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Device: FFR-measurement with different pressure guidewires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Scheduled to undergo invasive FFR measurement Coronary artery lesions located in the proximal or mid part of the coronary artery Reference diameter of at least 2.0mm Exclusion Criteria: Severe aortic valve stenosis known conduction disturbances (second- or third-degree AV block) acute myocardial infarction (CK >1,000 U/L less than 5 days ago) bradycardia (less than 45 beats/min) severe hypotension extremely tortuous or calcified coronary arteries precluding FFR measurement history of severe asthma pregnancy inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a prospective single center randomized controlled trial of FFR measurements comparing two commercially available pressure guidewires in consecutive patients undergoing routine FFR measurements in the catheterization laboratory.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wirecath - PressureWire X<br>Patients will undergo simultaneous FFR measurements with the Wirecath and PressureWire X simultaneously. | Device: FFR-measurement with different pressure guidewires<br>* Measuring FFR with different pressure guidewires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFR | To compare the pressure signals measured by the different available pressure guidewires, specifically the FFR value | During catheterization | 
| Hydrostatic error | To assess the occurrence of hydrostatic errors when using sensor-tipped wires | During catheterization | 
| Drift | To assess the occurrence of drift between the different pressure guidewires | During catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal quality | To assess signal quality and stability between the different pressure guidewires | During catheterization | 
| Maneuverability | To assess maneuverability and handling of the different pressure guidewires | During catheterization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional Flow Reserve, Pressure wire, Drift