Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

March 19, 2012 updated by: Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board

Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice

Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

  • To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
  • To investigate the influence of hyperemia on iFR.
  • To test reproducibility of iFR and FFR.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

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

  • Belgium
      • Aalst, Belgium
        • Cardiovascular Center Aalst
  • Czech Republic
      • Brno, Czech Republic
        • University Hospital Brno
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
  • Sweden
      • Stockholm, Sweden
        • Stockholm South Hospital
  • United States
    • California
      • Stanford, California, United States
        • Stanford University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.

Description

Inclusion Criteria:

  • all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria:

  • prior CABG
  • extremely tortuous, calcified lesions
  • coronary artery occlusion
  • acute MI within 5 days

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
FFR; iFR
Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
Time Frame: 30 days
In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iFR at rest vs iFr during hyperemia
Time Frame: 30 days
iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.
30 days
Repeatability of iFr and FFR
Time Frame: 30 days
To test repeatability of iFR and FFR
30 days

Collaborators and Investigators

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

Sponsor

NHS National Waiting Times Centre Board

Collaborators

Stanford University
Catharina Ziekenhuis Eindhoven
Onze Lieve Vrouw Hospital
Brno University Hospital
Stockholm South General Hospital
Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Prof Keith G. Oldroyd, Golden Jubilee National Hospital
  • Principal Investigator: Prof Colin Berry, MD, Golden Jubilee National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 14, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version F 2nd Jan 2012

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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