Coronary Artery DiseaseFAVOR II EJNCT02959814
Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan
An observational study of Coronary Artery Disease, run by Aarhus University Hospital Skejby at 10 sites in 7 countries.
Trial summary
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- QFR (observational)
- How many people
- 329 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 22 Feb 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis
Who may be able to join
- Stable angina pectoris or secondary evaluation of stenosis after acute MI
- Age > 18 years
- Able to provide signed informed consent
- Angiographic inclusion criteria:
- Indication for FFR in at least one stenosis:
- Diameter stenosis of 30%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Who cannot join
- Myocardial infarction within 72 hours
- Severe asthma or severe chronic obstructive pulmonary disease
- Severe heart failure (NYHA≥III)
- S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- Allergy to contrast media or adenosine
- Atrial fibrillation
Show all 18Show fewer
- Angiographic exclusion criteria:
- Lesion specific
- Below 30% and above 90% diameter stenosis by visual estimate.
- Reference size of vessel below 2 mm by visual estimation.
- Ostial LMCA lesions
- Ostial RCA lesions
- Distal LMCA lesions in combination with proximal Cx lesions
- Other bifurcation stenosis with lesions on both sides of a major shift (>1mm) in reference diameter Angiographic quality
- Poor image quality precluding contour detection
- Good contrast filling not possible
- Severe overlap of stenosed segments
- Severe tortuosity of target vessel
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Italy3 sites
Azienda ospedaliera Sant'Anna e S. sebastiano di Caserta
Caserta
Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara
Ferrara, 44124
Ospedale dell'Angelo di Mestre
Mestre, 30174
Germany2 sites
Elizabeth Krankenhaus Essen
Essen
Universitätsklinikum Gießen
Giessen, 35392
About this study
Official title: Diagnostic Accuracy of On-line Quantitative Flow Ratio. Functional Assessment by Virtual Online Reconstruction (The FAVOR II Europe-Japan Study)
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as gold standard.
Read the detailed description
Background:
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia).
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperaemia limits more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections.
The FAVOR I study (Tu et al.), showed promising results for core laboratory QFR analysis in selected patients.
The purpose of the FAVOR II study is to evaluate the feasibility and diagnostic precision of in-procedure QFR during CAG in comparison to QCA with FFR as gold standard for physiological lesion evaluation.
Hypothesis: QFR has superior sensitivity and specificity for detection of functional significant lesions in comparison to QCA with FFR as gold standard
Methods: Prospective, observational, multicenter study with inclusion of 310 patients.
Patients with indication for FFR are enrolled. At least two angiographic projections are acquired during resting conditions. QFR is calculated in-procedure using the Medis Suite application and simultaneously to the operator performing the FFR measurement. The QFR observer is blinded to the FFR measurement.
QFR is reassessed off-line by the Interventional Coronary Imaging Core Laboratory, Aarhus University, Denmark, blinded to FFR and in-procedure QFR results.
FFR is assessed by core laboratory reading, blinded to QFR results. All data are entered and stored in a protected and logged trial management system (TrialPartner, Aarhus University, Denmark).
- Conditions
- Coronary Artery Disease
- Being tested
- QFR (observational)
- Keywords
- Fractional Flow Reserve, Quantitative Coronary Analysis, Stable coronary artery disease, Angina pectoris
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR (observational)Other
QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter Stenosis (DS%) Assessed by 2D QCA of FFR Positive Patients (True Positives)
Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80. Positive DS% is defined as DS% > 50%
Measured: 1 hour
Specificity: Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) Compared to Proportion of Patients With Negative DS% Assessed by 2D QCA of FFR Negative Patients (True Negatives)
Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80. Negative DS% is defined as DS% ≤ 50%.
Measured: 1 hour
Secondary outcomes (14)
Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility)
Measured: 1 hour
Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) (Sensitivity)
Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
Measured: 1 hour
Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) (Specificity)
Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80
Measured: 1 hour
Proportion of Patients With Positive FFR (True Positives) of Patients With Positive QFR (Positive Predictive Value)
Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80
Measured: 1 hour
Proportion of Patients With Negative FFR (True Negatives) of Patients With Negative QFR (Negative Predictive Value)
Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80
Measured: 1 hour
Diagnostic Performance of QFR in Comparison to FFR Reported as Positive and Negative Likelihood Ratio
Positive likelihood ratio is defined as sensitivity/(1-specificity). Negative likelihood ratio is defined as (1-sensitivty)/specificity
Measured: 1 hour
Diagnostic Grey Zone Calculation. QFR Limits for Achieving 95% Sensitivity and Specificity in Comparison to FFR
QFR limits to yield 95% sensitivity and specificity. The QFR limits are identified by Area under the receiver operating curve analysis.
QFR limits are defined as the numerical QFR ratios (0-1.00).
Measured: 1 hour
Diagnostic Accuracy of TIMI-flow Based QFR in Comparison to 2D QCA (>50% Diameter Stenosis)
Comparison of proportion of participants correctly classified by QFR and 2D QCA using FFR as reference standard.
Diagnostic accuracy is defined as (true positives + false negatives) / (true positives+false positives+true negatives+false negatives).
Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80. Negative FFR is defines as FFR>0.80. Negative QFR is defines as QFR>0.80. Positive 2D QCA is defined as 2D-QCA % percent diameter stenosis >50. Negative 2D QCA is defined as 2D-QCA % diameter stenosis≤50.
Measured: 1 hour
Participants With Myocardial Infarction (Number of Patients)
Peri-procedural myocardial infarction
Measured: 1 day
All-cause Mortality (Number of Patients)
Peri-procedural mortality
Measured: 1 day
Time to FFR
Time from starting preparations to do FFR (e.g. ordering assistants to prepare pressure wire, adenosine infusion etc.) to FFR value is obtained and drift has been verified to be within the prespecified limits
Measured: 1 hour
Time to QFR After Receiving Angiographic Images
Time from first image evaluation on QFR computer until TIMI frame count based QFR value is obtained
Measured: 1 hour
Contrast Use
Volume of contrast for total procedure
Measured: 1 hour
Fluoroscopy Time
Fluoroscopy time for total procedure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start22 Feb 2017
- Primary completion17 Oct 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Ramsing Holm, Aarhus University Hospital Skejby
- Investigators
- Niels R. Holm, M.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959814
- Sponsor's protocol ID
- 1-10-72-219-16
- Acronym
- FAVOR II EJ
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2016
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
PubMed 27712739Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
PubMed 29980523
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of On-line Quantitative Flow Ratio. Functional Assessment by Virtual Online Reconstruction (The FAVOR II Europe-Japan Study)
- ClinicalTrials.gov ID
- NCT02959814
- Acronym / sponsor ID
- FAVOR II EJ / 1-10-72-219-16
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional Flow Reserve, Quantitative Coronary Analysis, Stable coronary artery disease, Angina pectoris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as gold standard.
Detailed description
Background:
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia).
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperaemia limits more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections.
The FAVOR I study (Tu et al.), showed promising results for core laboratory QFR analysis in selected patients.
The purpose of the FAVOR II study is to evaluate the feasibility and diagnostic precision of in-procedure QFR during CAG in comparison to QCA with FFR as gold standard for physiological lesion evaluation.
Hypothesis: QFR has superior sensitivity and specificity for detection of functional significant lesions in comparison to QCA with FFR as gold standard
Methods: Prospective, observational, multicenter study with inclusion of 310 patients.
Patients with indication for FFR are enrolled. At least two angiographic projections are acquired during resting conditions. QFR is calculated in-procedure using the Medis Suite application and simultaneously to the operator performing the FFR measurement. The QFR observer is blinded to the FFR measurement.
QFR is reassessed off-line by the Interventional Coronary Imaging Core Laboratory, Aarhus University, Denmark, blinded to FFR and in-procedure QFR results.
FFR is assessed by core laboratory reading, blinded to QFR results. All data are entered and stored in a protected and logged trial management system (TrialPartner, Aarhus University, Denmark).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis
Key inclusion criteria (7 listed)
- Stable angina pectoris or secondary evaluation of stenosis after acute MI
- Age > 18 years
- Able to provide signed informed consent
- Angiographic inclusion criteria:
- Indication for FFR in at least one stenosis:
Key exclusion criteria (18 listed)
- Myocardial infarction within 72 hours
- Severe asthma or severe chronic obstructive pulmonary disease
- Severe heart failure (NYHA≥III)
- S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- Allergy to contrast media or adenosine
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 |
|---|---|---|
| QFR (observational)QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands | Other | – |
Primary outcome
Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter Stenosis (DS%) Assessed by 2D QCA of FFR Positive Patients (True Positives)
Time frame: 1 hour
Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80. Positive DS% is defined as DS% > 50%
Specificity: Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) Compared to Proportion of Patients With Negative DS% Assessed by 2D QCA of FFR Negative Patients (True Negatives)
Time frame: 1 hour
Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80. Negative DS% is defined as DS% ≤ 50%.
14 secondary outcomes
Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility)
Time frame: 1 hour
Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) (Sensitivity)
Time frame: 1 hour
Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) (Specificity)
Time frame: 1 hour
Proportion of Patients With Positive FFR (True Positives) of Patients With Positive QFR (Positive Predictive Value)
Time frame: 1 hour
Proportion of Patients With Negative FFR (True Negatives) of Patients With Negative QFR (Negative Predictive Value)
Time frame: 1 hour
Diagnostic Performance of QFR in Comparison to FFR Reported as Positive and Negative Likelihood Ratio
Time frame: 1 hour
Diagnostic Grey Zone Calculation. QFR Limits for Achieving 95% Sensitivity and Specificity in Comparison to FFR
Time frame: 1 hour
Diagnostic Accuracy of TIMI-flow Based QFR in Comparison to 2D QCA (>50% Diameter Stenosis)
Time frame: 1 hour
Participants With Myocardial Infarction (Number of Patients)
Time frame: 1 day
All-cause Mortality (Number of Patients)
Time frame: 1 day
Time to FFR
Time frame: 1 hour
Time to QFR After Receiving Angiographic Images
Time frame: 1 hour
Contrast Use
Time frame: 1 hour
Fluoroscopy Time
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27712739Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
- Derived from this study: PubMed 29980523Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
- Individual participant dataSharing planned: Undecided
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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.
Niels R. Holm, M.D. principal investigator
Aarhus University Hospital
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Aarhus University Hospital Skejby at 10 sites in 7 countries.
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 7 inclusion and 18 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Germany, Denmark, France, Japan and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter Stenosis (DS%) Assessed by 2D QCA of FFR Positive Patients (True Positives) (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT02959814, 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 13 Jan 2020.