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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT03815032

Collaborator

Opsens Medical (Other)

Enrollment

Location

Arms

13.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Stenosis Atherosclerosis Atherosclerosis, Coronary Angina, Stable Angina, Unstable NSTEMI - Non-ST Segment Elevation MI	Device: Drift assessment of OptoWire Deux FFR wire (1) Device: Drift assessment of OptoWire Deux FFR wire (2)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

delta FFR [Day 1]
To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.