Angina, Stable, Angina, Unstable, Atherosclerosis, Atherosclerosis, Coronary, Coronary Artery Disease, Coronary Stenosis, NSTEMI - Non-ST Segment Elevation MI
Conditions
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.
Interventions
DEVICEDrift 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.
DEVICEDrift 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.
Sponsors
Opsens, Inc.
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delta FFR | Day 1 | To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drift recording | Day 1 | The rate of significant drift, defined as Pd/Pa \<0.97 or \>1.03 |
| Delta from guidewire to guidewire | Day 1 | Assess the magnitude of reading delta from guidewire to guidewire prior to equalization. |
| Stents | Day 1 | The number of stents used. |
| Stents on FFR wire | Day 1 | The number of stents placed over an OptoWire DeuxTM guidewire. |
| Workhorse guidewire | Day 1 | Number of Workhorse guidewire used. |
Countries
Canada
Outcome results
None listed