Trials / Completed
CompletedNCT03815032
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Artery Disease
- Coronary Stenosis
- Atherosclerosis
- Atherosclerosis, Coronary
- Angina, Stable
- Angina, Unstable
- NSTEMI - Non-ST Segment Elevation MI
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drift assessment of OptoWire Deux FFR wire (1) | Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any. |
| DEVICE | Drift assessment of OptoWire Deux FFR wire (2) | Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any. |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2020-01-30
- Completion
- 2020-03-31
- First posted
- 2019-01-24
- Last updated
- 2020-07-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03815032. Inclusion in this directory is not an endorsement.