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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01559493

Enrollment

200

Registered

2012-03-21

Start date

2012-01-31

Completion date

2012-02-29

Last updated

2012-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Plaque, Atherosclerotic

Keywords

atherosclerotic lesion assessment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice	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

Measure	Time frame	Description
iFR at rest vs iFr during hyperemia	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	30 days	To test repeatability of iFR and FFR

Countries

Belgium, Czechia, Netherlands, Sweden, United States

Outcome results