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Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison (ACCURACY)

Primary Purpose

Coronary Artery Disease, Coronary Stenosis, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Drift assessment of OptoWire Deux FFR wire (1)
Drift assessment of OptoWire Deux FFR wire (2)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Single de novo coronary lesion or in-stent restenosis lesion with an operator assessed reference diameter ≥2.0 mm requiring FFR measurement based on the operator's clinical judgment

Exclusion Criteria:

  • Patients with ST-segment-elevation myocardial infarction (STEMI), culprit lesion of non-ST-segment-elevation myocardial infarction (NSTEMI), New York Heart Association class IV heart failure, suspected or visible thrombus, dissection or excessive calcification or tortuosity in the target vessel, or a stenosis in a bypass graft will be excluded.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Optowire Deux FFR assessment (1)

Optowire Deux FFR assessment (2)

Arm Description

A total of 45 consecutive patients will be recruited: group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires

group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire

Outcomes

Primary Outcome Measures

delta FFR
To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention

Secondary Outcome Measures

Drift recording
The rate of significant drift, defined as Pd/Pa <0.97 or >1.03
Delta from guidewire to guidewire
Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.
Stents
The number of stents used.
Stents on FFR wire
The number of stents placed over an OptoWire DeuxTM guidewire.
Workhorse guidewire
Number of Workhorse guidewire used.

Full Information

First Posted
January 7, 2019
Last Updated
July 16, 2020
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Opsens, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03815032
Brief Title
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
Acronym
ACCURACY
Official Title
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Opsens, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
This is a single center, prospective, non-blinded clinical investigation enrolling consecutive patients with coronary lesion candidate for FFR assessment. The study aim 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, n=30). In addition, The investigators will compare (group 2, n=15) 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. The clinical investigation will be conducted in the Centre Hospitalier de l'Université de Montréal (CHUM). No clinical follow-up is requested after the end of the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, Atherosclerosis, Coronary, Angina, Stable, Angina, Unstable, NSTEMI - Non-ST Segment Elevation MI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optowire Deux FFR assessment (1)
Arm Type
Experimental
Arm Description
A total of 45 consecutive patients will be recruited: group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires
Arm Title
Optowire Deux FFR assessment (2)
Arm Type
Experimental
Arm Description
group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire
Intervention Type
Device
Intervention Name(s)
Drift assessment of OptoWire Deux FFR wire (1)
Intervention Description
Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
Intervention Type
Device
Intervention Name(s)
Drift assessment of OptoWire Deux FFR wire (2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
delta FFR
Description
To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Drift recording
Description
The rate of significant drift, defined as Pd/Pa <0.97 or >1.03
Time Frame
Day 1
Title
Delta from guidewire to guidewire
Description
Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.
Time Frame
Day 1
Title
Stents
Description
The number of stents used.
Time Frame
Day 1
Title
Stents on FFR wire
Description
The number of stents placed over an OptoWire DeuxTM guidewire.
Time Frame
Day 1
Title
Workhorse guidewire
Description
Number of Workhorse guidewire used.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Single de novo coronary lesion or in-stent restenosis lesion with an operator assessed reference diameter ≥2.0 mm requiring FFR measurement based on the operator's clinical judgment Exclusion Criteria: Patients with ST-segment-elevation myocardial infarction (STEMI), culprit lesion of non-ST-segment-elevation myocardial infarction (NSTEMI), New York Heart Association class IV heart failure, suspected or visible thrombus, dissection or excessive calcification or tortuosity in the target vessel, or a stenosis in a bypass graft will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer Mansour, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X0C1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26868697
Citation
Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. No abstract available.
Results Reference
background
PubMed Identifier
24799502
Citation
Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. No abstract available.
Results Reference
result

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

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