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OpenTrials
Completed

NCT Number: NCT03052803

Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CAEN University Hospital

Caen, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional flow reserve measure

Device

Comparison of different devices measuring fractional flow reserve

Primary outcomes

  1. Simultaneous FFR measure SJM and ACIST

    Time frame: Immediately

    Correlation between simultaneous measures with St Jude medical FFR device and ACIST device

  2. Simultaneous FFR measure Boston Scientific and ACIST

    Time frame: Immediately

    Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device

  3. Simultaneous FFR measure Boston Scientific and SJM

    Time frame: Immediately

    Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device

Secondary outcomes

  1. FFR SJM or Boston alone versus simultaneous with ACIST

    Time frame: Immediately

    Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST

  2. Clinical concordance

    Time frame: Immediately

    Concordance between FFR values >0.80 or <=0.80

  3. Drift of the signal

    Time frame: immediately

    variation between the initial measure in the aorta (equalization) and final measure

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Abbott Medical Devices
  • Acist Medical Systems
  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: FFR-DS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 14, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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