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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

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

Treatments: Device: Drift assessment of OptoWire Deux FFR wire (2); Device: Drift assessment of OptoWire Deux FFR wire (1)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03815032

18.238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Optowire Deux FFR assessment (1)

Experimental group

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

Treatment:

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

Optowire Deux FFR assessment (2)

Experimental group

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

Treatment:

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