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

This study has been completed.

Sponsor:

Collaborators:

Golden Jubilee National Hospital

Catharina Ziekenhuis Eindhoven

Onze Lieve Vrouw Hospital

Stockholm South General Hospital

Brno University Hospital

Stanford University

Information provided by (Responsible Party):

Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board

ClinicalTrials.gov Identifier:

NCT01559493

First received: February 14, 2012

Last updated: March 19, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2012

Last Updated Date

March 19, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01559493 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

iFR at rest vs iFr during hyperemia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.
Repeatability of iFr and FFR [ Time Frame: 30 days ] [ Designated as safety issue: No ]
To test repeatability of iFR and FFR

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Coronary Artery Disease
Plaque, Atherosclerotic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

FFR; iFR

Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

Publications *

Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

February 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Czech Republic, Netherlands, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01559493

Other Study ID Numbers ^ICMJE

Version F 2nd Jan 2012

Has Data Monitoring Committee

Responsible Party

Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board

Study Sponsor ^ICMJE

NHS National Waiting Times Centre Board

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

NHS National Waiting Times Centre Board

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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