CompletedNot Applicable

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

Canada45 participantsStarted 2019-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

delta FFR

Timeframe: Day 1

Trial details

NCT IDNCT03815032

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-30

View on ClinicalTrials.gov More Coronary Artery Disease trials