Coronary Artery DiseaseACCURACYNCT03815032
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
A study testing Drift assessment of OptoWire Deux FFR wire (1) and Drift assessment of OptoWire Deux FFR wire (2) in people with Coronary Artery Disease and Coronary Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis
- What is being tested?
- Drift assessment of OptoWire Deux FFR wire (1) and Drift assessment of OptoWire Deux FFR wire (2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X0C1
About this study
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.
Read the 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
- Being tested
- Drift assessment of OptoWire Deux FFR wire (1), Drift assessment of OptoWire Deux FFR wire (2)
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drift assessment of OptoWire Deux FFR wire (1)Device
Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
Drift assessment of OptoWire Deux FFR wire (2)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Optowire Deux FFR assessment (1) | Experimental | A total of 45 consecutive patients will be recruited:
group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires Receives: Device: Drift assessment of OptoWire Deux FFR wire (1) |
| Optowire Deux FFR assessment (2) | Experimental | group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire Receives: Device: Drift assessment of OptoWire Deux FFR wire (2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta FFR
To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention
Measured: Day 1
Secondary outcomes (5)
Drift recording
The rate of significant drift, defined as Pd/Pa <0.97 or >1.03
Measured: Day 1
Delta from guidewire to guidewire
Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.
Measured: Day 1
Stents
The number of stents used.
Measured: Day 1
Stents on FFR wire
The number of stents placed over an OptoWire DeuxTM guidewire.
Measured: Day 1
Workhorse guidewire
Number of Workhorse guidewire used.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Feb 2019
- Primary completion30 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Opsens, Inc.
- Responsible party
- Sponsor
- Investigators
- Samer Mansour, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815032
- Sponsor's protocol ID
- 18.238
- Acronym
- ACCURACY
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. No abstract available.
PubMed 26868697Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. No abstract available.
PubMed 24799502
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison
- ClinicalTrials.gov ID
- NCT03815032
- Acronym / sponsor ID
- ACCURACY / 18.238
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, Atherosclerosis, Coronary, Angina, Stable, Angina, Unstable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Opsens, Inc.
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optowire Deux FFR assessment (1) | Experimental | Device: Drift assessment of OptoWire Deux FFR wire (1)A total of 45 consecutive patients will be recruited: group 1 (n=30): To assess the differences in FFR measurements (drift) made by the OptoWire Deux FFRTM guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires |
| Optowire Deux FFR assessment (2) | Experimental | Device: Drift assessment of OptoWire Deux FFR wire (2)group 2 (n=15): To assess the differences in FFR measurements (drift) obtained from an OptoWire DeuxTM FFR guidewire and compare it to the FFR measurement by a VERRATATM guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Optowire Deux FFR assessment (1) |
| 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. | Device | Optowire Deux FFR assessment (2) |
Primary outcome
delta FFR
Time frame: Day 1
To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention
5 secondary outcomes
Drift recording
Time frame: Day 1
Delta from guidewire to guidewire
Time frame: Day 1
Stents
Time frame: Day 1
Stents on FFR wire
Time frame: Day 1
Workhorse guidewire
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Background: PubMed 26868697Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. No abstract available.
- Results publication: PubMed 24799502Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samer Mansour, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drift assessment of OptoWire Deux FFR wire (1) and Drift assessment of OptoWire Deux FFR wire (2) in people with Coronary Artery Disease and Coronary Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta FFR (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.