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

Not Applicable

Completed

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

• Registration Number: NCT03815032
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-24
• Study Start: 2019-02-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-03-31
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optowire Deux FFR assessment (2)	Drift assessment of OptoWire Deux FFR wire (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
Optowire Deux FFR assessment (1)	Drift assessment of OptoWire Deux FFR wire (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

Primary Outcome Measures

Name	Time	Method
delta FFR	Day 1	To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada