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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFR (observational) | Other | QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 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%. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Lesion specific
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Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Niels R. Holm, M.D. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hspital | Aarhus N | 8200 | Denmark | |||
| Institut Cardiovasculaire Paris Sud Massy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27712739 | Background | 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. | |
| 29980523 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Paired QFR, FFR and 2D-QCA | Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Paired QFR, FFR and 2D-QCA | Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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% | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Paired QFR, FFR and 2D-QCA | Patients with stable angina pectoris or secondary evaluation of stenosis after acute MI reffered to invasive coronary angiography (ICA). ICA revealed at least one lesion with 30-90 % diameter stenosis with indication for fractional flow reserve (FFR). No lesions were excluded by the FFR, 2D-QCA nor angiographic criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niels Ramsing Holm, MD | Skejby University Hospital, Denmark | 004526849066 | Niels.holm@clin.au.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2016 | Jan 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 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 | 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 | 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 | 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). | 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. | 1 hour |
| Participants With Myocardial Infarction (Number of Patients) | Peri-procedural myocardial infarction | 1 day |
| All-cause Mortality (Number of Patients) | Peri-procedural mortality | 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 | 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 | 1 hour |
| Contrast Use | Volume of contrast for total procedure | 1 hour |
| Fluoroscopy Time | Fluoroscopy time for total procedure | 1 hour |
| Massy |
| France |
| Elizabeth Krankenhaus Essen | Essen | Germany |
| Universitätsklinikum Gießen | Giessen | 35392 | Germany |
| Azienda ospedaliera Sant'Anna e S. sebastiano di Caserta | Caserta | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara | Ferrara | 44124 | Italy |
| Ospedale dell'Angelo di Mestre | Mestre | 30174 | Italy |
| Gifu Heart Center | Gifu | Japan |
| HagaZiekenhuis | The Hague | 2545 | Netherlands |
| Golden Jubilee National Hospital | Glasgow | G81 4DY | United Kingdom |
| Derived |
| Westra 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. |
| FFR not measured |
|
| In-procedure QFR not computed |
|
| Excluded by FFR core-lab |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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%. | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
|
|
| Secondary | Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility) | Patients with successful FFR Measurement before Exclusion based on missing QFR and/or 2D-QCA | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Proportion | 1 hour |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Ratio | 1 hour |
|
|
|
| Secondary | 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). | Posted | Number | Ratio | 1 hour |
|
|
|
| Secondary | 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. | Posted | Number | Proportion | 1 hour |
|
|
|
| Secondary | Participants With Myocardial Infarction (Number of Patients) | Peri-procedural myocardial infarction | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | All-cause Mortality (Number of Patients) | Peri-procedural mortality | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Minutes | 1 hour |
|
|
|
| Secondary | Time to QFR After Receiving Angiographic Images | Time from first image evaluation on QFR computer until TIMI frame count based QFR value is obtained | Posted | Mean | Inter-Quartile Range | Minutes | 1 hour |
|
|
|
| Secondary | Contrast Use | Volume of contrast for total procedure | Posted | Mean | Standard Deviation | mL | 1 hour |
|
|
|
| Secondary | Fluoroscopy Time | Fluoroscopy time for total procedure | Posted | Mean | Standard Deviation | Minutes | 1 hour |
|
|
|
| 0 |
| 329 |
| 0 |
| 329 |
| 0 |
| 329 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |