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

* 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Center Aalst, Aalst, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.
Repeatability of iFr and FFR

Time frame: 30 days

To test repeatability of iFR and FFR

Sponsors and collaborators

Lead sponsor

NHS National Waiting Times Centre Board

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 21, 2012
Registry last updated: Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed