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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atherosclerosis; Angina, Stable; Angina, Unstable; Coronary Stenosis; NSTEMI - Non-ST Segment Elevation MI; Atherosclerosis, Coronary
• Intervention / Treatment: Device: Drift assessment of OptoWire Deux FFR wire (1); Device: Drift assessment of OptoWire Deux FFR wire (2)

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X0C1
      • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Optowire Deux FFR assessment (1); 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); Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
EXPERIMENTAL: Optowire Deux FFR assessment (2); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delta FFR	To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drift recording	The rate of significant drift, defined as Pd/Pa <0.97 or >1.03	Day 1
Delta from guidewire to guidewire	Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.	Day 1
Stents	The number of stents used.	Day 1
Stents on FFR wire	The number of stents placed over an OptoWire DeuxTM guidewire.	Day 1
Workhorse guidewire	Number of Workhorse guidewire used.	Day 1

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Opsens, Inc.
• Investigators: Principal Investigator: Samer Mansour, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (ACTUAL): January 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Angina Pectoris; Angina, Stable; Angina, Unstable; Coronary Stenosis
• Other Study ID Numbers: 18.238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No