Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison (NCT03815032) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
delta FFR
Timeframe: Day 1
Trial details
NCT IDNCT03815032
SponsorCentre hospitalier de l'Université de Montréal (CHUM)