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Pressure Guidewire Comparison

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ClinicalTrials.gov Identifier: NCT04802681
Recruitment Status : Completed
First Posted : March 17, 2021
Last Update Posted : July 17, 2023
Sponsor:
Collaborator:
Cavis Technologies AB
Information provided by (Responsible Party):
Lokien van Nunen, Catharina Ziekenhuis Eindhoven

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Device: FFR-measurement with different pressure guidewires Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
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
Official Title: Piezo-electric Versus Open Wire Pressure Guidewires for FFR Measurements: Comparison of Two Commercially Available Pressure Wires
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : January 19, 2023
Actual Study Completion Date : January 19, 2023
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. FFR [ Time Frame: During catheterization ]
    To compare the pressure signals measured by the different available pressure guidewires, specifically the FFR value

  2. Hydrostatic error [ Time Frame: During catheterization ]
    To assess the occurrence of hydrostatic errors when using sensor-tipped wires

  3. Drift [ Time Frame: During catheterization ]
    To assess the occurrence of drift between the different pressure guidewires


Secondary Outcome Measures :
  1. Signal quality [ Time Frame: During catheterization ]
    To assess signal quality and stability between the different pressure guidewires

  2. Maneuverability [ Time Frame: During catheterization ]
    To assess maneuverability and handling of the different pressure guidewires


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802681


Locations
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Netherlands
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623EJ
Sponsors and Collaborators
Lokien van Nunen
Cavis Technologies AB
More Information
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Responsible Party: Lokien van Nunen, Fellow Interventional Cardiology, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT04802681    
Other Study ID Numbers: PW-COMPARE
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual (non-anonymized) participant data available to others.

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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
Keywords provided by Lokien van Nunen, Catharina Ziekenhuis Eindhoven:
Fractional Flow Reserve
Pressure wire
Drift
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes