Pressure Guidewire Comparison

July 14, 2023 updated by: Lokien van Nunen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Wirecath - PressureWire X
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lokien van Nunen

Collaborators

Cavis Technologies AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PW-COMPARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual (non-anonymized) participant data available to others.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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