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Pressure Guidewire Comparison

NCT04802681 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

FFR-measurement with different pressure guidewires

Measuring FFR with different pressure guidewires

Sponsors & Collaborators

  • Cavis Technologies AB

    collaborator INDUSTRY

  • Lokien van Nunen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-01-19
Completion
2023-01-19

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802681 on ClinicalTrials.gov