Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

Study Overview
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Brief Summary
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The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.

Detailed Description
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The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability. Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing. The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.

Official Title
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Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)

Conditions
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Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia

Intervention / Treatment
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* Device: Fractional flow reserve measure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized at Caen University Hospital for coronary angiography Coronary stenosis needing FFR evaluation according to recommendations More than 18 years old Clinically stable De novo coronary stenosis Affiliated to social security Informed consent signed Exclusion Criteria: Unstable patients defined by acute coronary syndrome < 7 days Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker) History of coronary artery bypass intra-stent restenosis Patient not capable of understanding the study Informed consent not signed

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

| Intervention/Treatment |
| --- |
|Device: Fractional flow reserve measure|Comparison of different devices measuring fractional flow reserve|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simultaneous FFR measure SJM and ACIST | Correlation between simultaneous measures with St Jude medical FFR device and ACIST device | Immediately | 
| Simultaneous FFR measure Boston Scientific and ACIST | Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device | Immediately | 
| Simultaneous FFR measure Boston Scientific and SJM | Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device | Immediately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFR SJM or Boston alone versus simultaneous with ACIST | Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST | Immediately | 
| Clinical concordance | Concordance between FFR values >0.80 or <=0.80 | Immediately | 
| Drift of the signal | variation between the initial measure in the aorta (equalization) and final measure | immediately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary stenosis, fractional flow reserve