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

February 14, 2012
March 19, 2012
January 2012
February 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01559493 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Coronary Artery Disease
  • Plaque, Atherosclerotic
Not Provided
FFR; iFR
Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement
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.
 
Completed
200
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   Netherlands,   Sweden
 
NCT01559493
Version F 2nd Jan 2012
No
Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
NHS National Waiting Times Centre Board
  • Golden Jubilee National Hospital
  • Catharina Ziekenhuis Eindhoven
  • Onze Lieve Vrouw Hospital
  • Stockholm South General Hospital
  • Brno University Hospital
  • Stanford University
Principal Investigator: Prof Keith G. Oldroyd Golden Jubilee National Hospital
Principal Investigator: Prof Colin Berry, MD Golden Jubilee National Hospital
NHS National Waiting Times Centre Board
March 2012

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