Pressure Guidewire Comparison
Condition: Coronary Artery Disease; Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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.
    

Intervention name(s): FFR-measurement with different pressure guidewires
Intervention type(s): Device
Intervention description(s): Measuring FFR with different pressure guidewires
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Diagnostic
Keywords: Fractional Flow Reserve; Pressure wire; Drift