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
  Purpose

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.

Condition
Coronary Artery Disease
Plaque, Atherosclerotic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice

Resource links provided by NLM:


Further study details as provided by NHS National Waiting Times Centre Board:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFR; iFR
Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559493

Locations
United States, California
Stanford University
Stanford, California, United States
Belgium
Cardiovascular Center Aalst
Aalst, Belgium
Czech Republic
University Hospital Brno
Brno, Czech Republic
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Sweden
Stockholm South Hospital
Stockholm, Sweden
Sponsors and Collaborators
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
Investigators
Principal Investigator: Prof Keith G. Oldroyd Golden Jubilee National Hospital
Principal Investigator: Prof Colin Berry, MD Golden Jubilee National Hospital
  More Information

No publications provided by NHS National Waiting Times Centre Board

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Keith G. Oldroyd, Consultant Cardiologist, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT01559493     History of Changes
Other Study ID Numbers: Version F 2nd Jan 2012
Study First Received: February 14, 2012
Last Updated: March 19, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS National Waiting Times Centre Board:
atherosclerotic lesion assessment

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Plaque, Atherosclerotic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014