Status:
COMPLETED
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Opsens, Inc.
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 gui...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03815032
Start Date
February 1 2019
End Date
March 31 2020
Last Update
July 20 2020
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X0C1