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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, Atherosclerosis, Coronary, Angina, Stable, Angina, Unstable, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
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* Device: Drift assessment of OptoWire Deux FFR wire (1)
* Device: Drift assessment of OptoWire Deux FFR wire (2)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |