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Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison

NCT03815032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-07-20

No results posted yet for this study

Summary

The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice.

Conditions

Interventions

DEVICE

Drift assessment of OptoWire Deux FFR wire (1)

Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.

DEVICE

Drift assessment of OptoWire Deux FFR wire (2)

Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any.

Sponsors & Collaborators

  • Opsens, Inc.

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Samer Mansour, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-01-30
Completion
2020-03-31

Countries

  • Canada

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 NCT03815032 on ClinicalTrials.gov