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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052803
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Acist Medical Systems
Abbott Medical Devices
Boston Scientific Corporation
Information provided by (Responsible Party):
University Hospital, Caen

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

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Stenosis Myocardial Ischemia Device: Fractional flow reserve measure

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017
Groups and Cohorts
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Intervention Details:
  • Device: Fractional flow reserve measure
    Comparison of different devices measuring fractional flow reserve

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052803


Locations
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France
CAEN University Hospital
Caen, France
Sponsors and Collaborators
University Hospital, Caen
Acist Medical Systems
Abbott Medical Devices
Boston Scientific Corporation
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03052803    
Other Study ID Numbers: 16-145
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University Hospital, Caen:
coronary stenosis
fractional flow reserve
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Stenosis
Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes