NCT03815032

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable 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

January 7, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 20, 2020

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 7, 2019

Last Update Submit

July 16, 2020

Conditions

Coronary Artery DiseaseCoronary StenosisAtherosclerosisAtherosclerosis, CoronaryAngina, StableAngina, UnstableNSTEMI - Non-ST Segment Elevation MI

Outcome Measures

Primary Outcomes (1)

  • delta FFR

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

    Day 1

Secondary Outcomes (5)

  • Drift recording

    Day 1

  • Delta from guidewire to guidewire

    Day 1

  • Stents

    Day 1

  • Stents on FFR wire

    Day 1

  • Workhorse guidewire

    Day 1

Study Arms (2)

Optowire Deux FFR assessment (1)

EXPERIMENTAL

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

Device: Drift assessment of OptoWire Deux FFR wire (1)

Optowire Deux FFR assessment (2)

EXPERIMENTAL

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

Device: Drift assessment of OptoWire Deux FFR wire (2)

Interventions

Drift assessment of OptoWire Deux FFR wire (1)DEVICE

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

Optowire Deux FFR assessment (1)
Drift assessment of OptoWire Deux FFR wire (2)DEVICE

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.

Optowire Deux FFR assessment (2)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X0C1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 26868697BACKGROUND

  • 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.

    PMID: 24799502RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary StenosisAtherosclerosisAngina, StableAngina, UnstableNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Samer Mansour, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 24, 2019

Study Start

February 1, 2019

Primary Completion

January 30, 2020

Study Completion

March 31, 2020

Last Updated

July 20, 2020

Record last verified: 2019-01

Locations

CA(1)