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Clinical Trials/NCT01559493
NCT01559493
Completed
Not Applicable

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

NHS National Waiting Times Centre Board5 sites in 5 countries200 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
NHS National Waiting Times Centre Board
Enrollment
200
Locations
5
Primary Endpoint
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
Status
Completed
Last Updated
14 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 2012
End Date
February 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
NHS National Waiting Times Centre Board
Responsible Party
Principal Investigator
Principal Investigator

Prof. Keith G. Oldroyd

Consultant Cardiologist

NHS National Waiting Times Centre Board

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • iFR at rest vs iFr during hyperemia(30 days)
  • Repeatability of iFr and FFR(30 days)

Study Sites (5)

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