NCT04802681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

March 15, 2021

Last Update Submit

July 14, 2023

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

Fractional Flow ReservePressure wireDrift

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Signal quality

    During catheterization

  • Maneuverability

    During catheterization

Study Arms (1)

Wirecath - PressureWire X

OTHER

Patients will undergo simultaneous FFR measurements with the Wirecath and PressureWire X simultaneously.

Device: FFR-measurement with different pressure guidewires

Interventions

FFR-measurement with different pressure guidewiresDEVICE

Measuring FFR with different pressure guidewires

Wirecath - PressureWire X

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Related Publications (2)

  • Eerdekens R, Tonino PAL, Zimmermann FM, Teeuwen K, Vlaar PJ, de Waard GA, van Royen N, van Nunen LX. Fluid-filled versus sensor-tipped pressure guidewires for FFR and Pd/Pa measurement; PW-COMPARE study. Int J Cardiol. 2024 Jul 1;406:131998. doi: 10.1016/j.ijcard.2024.131998. Epub 2024 Mar 28.

    PMID: 38555057DERIVED

  • Ramunddal T, Dworeck C, Torild P, Andreen S, Gan LM, Hirlekar G, Ioanes D, Myredal A, Odenstedt J, Petursson P, Pylova T, Topel F, Volz S, Hilmersson M, Redfors B, Angeras O. Safety and Feasibility Using a Fluid-Filled Wire to Avoid Hydrostatic Errors in Physiological Intracoronary Measurements. Cardiol Res Pract. 2024 Jan 2;2024:6664482. doi: 10.1155/2024/6664482. eCollection 2024.

    PMID: 38204600DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fellow Interventional Cardiology

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 17, 2021

Study Start

December 1, 2021

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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

Locations

NL(1)