Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries (FFR-DS)

January 24, 2018 updated by: University Hospital, Caen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Caen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simultaneous FFR measure SJM and ACIST
Time Frame: Immediately
Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Immediately
Simultaneous FFR measure Boston Scientific and ACIST
Time Frame: Immediately
Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Immediately
Simultaneous FFR measure Boston Scientific and SJM
Time Frame: Immediately
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
Time Frame: Immediately
Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST
Immediately
Clinical concordance
Time Frame: Immediately
Concordance between FFR values >0.80 or <=0.80
Immediately
Drift of the signal
Time Frame: immediately
variation between the initial measure in the aorta (equalization) and final measure
immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Boston Scientific Corporation
Abbott Medical Devices
Acist Medical Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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