The Wire-free Invasive Functional Imaging (WIFI) Study

Study Overview
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Brief Summary
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Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.

Detailed Description
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Background: Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG) and often in combination with measurement of fractional flow reserve (FFR) to assess the 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 maximum blood flow (hyperaemia) induced by adenosine infusion. 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 and 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 in the vessel based on two angiographic projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR. Hypothesis: QFR can be assessed during CAG for stenosis interrogated by FFR Methods: Proof-of-concept, prospective, observational, single arm study with inclusion of 100 patients. Clinical follow-up by telephone call after one year. A stenosis with indication for FFR is identified and at least two angiographic projections rotated at least 25 degrees around the target vessel are acquired during resting conditions. QFR is calculated on-line using the Medis Suite application and simultaneously to the operator performing the FFR measurement using I.V. adenosine. The QFR observer is blinded to the FFR measurement. QFR is reassessed off-line by internal observer and by an external core laboratory. Both blinded to FFR results. FFR is assessed in core laboratory by a different blinded observer All data are entered and stored in a protected and logged trial management system (TrialPartner).

Official Title
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Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: QFR (observational)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI) Age > 18 years Signed informed consent Exclusion Criteria: Myocardial infarction within 72 hours Severe asthma and chronic obstructive pulmonary disease Severe heart failure (NYHA≥III) S-creatinine>120µmol/L Allergy to contrast media or adenosine Stenosis in vein graft Ostial left main stenosis Severe tortuosity Atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QFR group<br>Patients with stable angina pectoris and indication for FFR. | Other: QFR (observational)<br>* QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of in-procedure QFR | Percentage of successful QFR in FFR-cases. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 hour | 
| Proportion of patients with negative QFR of patients with negative FFR (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 |  | 1 hour | 
| Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis) | Defined as area under the receiver operating curve (ROC) | 1 hour | 
| Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis) | Defined as area under the receiver operating curve (ROC) | 1 hour | 
| Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis) | Defined as area under the receiver operating curve (ROC) | 1 hour | 
| Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis) | Defined as area under the receiver operating curve (ROC) | 1 hour | 
| Any QFR procedure-related adverse events/complications (safety) | Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections. | 1 hour | 
| Time to FFR | From last diagnostic angiogram before advancing FFR-wire to approved drift-check | 1 hour | 
| Time to QFR | From receiving angiographic images to QFR-value | 1 hour | 
| Contrast use | Volume of contrast for total procedure | 1 hour | 
| Fluoroscopy time |  | 1 hour | 
| Myocardial infarction | Universal definition | 1 year | 
| Target lesion failure | Universal definition | 1 year | 
| Target lesion revascularization | Universal definition | 1 year | 
| Stent thrombosis | Universal definition | 1 year | 
| Angina pectoris | Canadian Cardiovascular Society (CCS)-class | 1 year | 
| Cardiac death | Universal definition | 1 year | 
| Non-cardiac death | Universal definition | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional Flow Reserve, Coronary Artery Disease