Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03052803

Acronym

FFR-DS

Enrollment

Registered

2017-02-14

Start date

2017-02-01

Completion date

2017-12-01

Last updated

2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia

Keywords

coronary stenosis, fractional flow reserve

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.

Interventions

DEVICEFractional flow reserve measure

Comparison of different devices measuring fractional flow reserve

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026