Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

Completed

• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis

• Registration Number: NCT03052803
• Lead Sponsor: University Hospital, Caen

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-14
• Status Verified: 2017-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Simultaneous FFR measure SJM and ACIST	Immediately	Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and ACIST	Immediately	Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Simultaneous FFR measure Boston Scientific and SJM	Immediately	Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CAEN University Hospital; 🇫🇷 Caen, France