Comparison of Fractional Flow Reserve and Intravascular Ultrasound

Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01133015

Enrollment

191

Registered

2010-05-28

Start date

2009-03-31

Completion date

2011-11-30

Last updated

2011-07-21

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

Conditions

Coronary Artery Stenosis

Keywords

FFR, IVUS, MLA

Brief summary

This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests which is done as a part of the cardiac catheterization.

Detailed description

Invasive X-ray coronary angiography remains the reference standard for the evaluation of coronary artery stenoses. Recently, intravascular ultrasound (IVUS) has been introduced as an invasive method for the evaluation of coronary artery stenoses and has been shown to be highly accurate in stenosis detection when compared to X-ray angiography. While invasive X-ray angiography and IVUS evaluate morphological features of coronary arterial plaques, fractional flow reserve (FFR) is an invasive measure of the hemodynamic significance of a stenosis obtained in the catheterization laboratory by measuring changes in intracoronary arterial pressure before and after maximal vasodilation induced by intravenous adenosine. An FFR value less than 0.75 has been shown to predict ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and has been shown to be associated with worse outcomes. Therefore, FFR is considered to be an invasive hemodynamic reference standard for the evaluation of the hemodynamic significance of coronary arterial stenoses. While IVUS can provide additional morphological information in intermediate stenoses, it can not provide further functional information. We are currently conducting investigation in the validation of IVUS against FFR in intermediate coronary artery stenoses in each coronary arteries. However, the difference of the values of IVUS data in each coronary artery, eg. left anterior descending artery or right coronary artery, has not been validated against invasive hemodynamic measurements of fractional flow reserve in patients with intermediate stenoses by invasive X-ray angiography. We hypothesize that IVUS-derived measurements are interpreted differently in each coronary arteries in the diagnosis of hemodynamically significant coronary artery stenoses, using FFR as the reference standard in patients with coronary artery stenoses 40%\< and \<70%.

Interventions

DEVICEFractional flow reserve

Fractional flow reserve measured by pressure wire

DEVICEIVUS

intravascular ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Age 21-85 * Presence of at least one obstructive coronary artery stenosis as defined by: * Previous catheterization or CT angiogram with any lesion 70% or greater * Previous positive functional stress test (this does not include CTA alone) * Ability and Willingness to provide informed consent * Ability and Willingness to perform required follow up procedures

Exclusion criteria

* History of coronary artery bypass graft surgery * Previously revascularized lesion * Creatinine\>1.6 mg/dL or GFR\<30 pre-procedure per institutional standards * Known Pregnancy * Inability to perform CTA * Arrhythmia precluding diagnostic CT examination * Contrast agent allergy that cannot be adequately premedicated * Severe PVD precluding cardiac catheterization * Patient not a candidate for IVUS and FFR * Inability or unwillingness to provide informed consent * Inability or unwillingness to perform required follow up procedures

Design outcomes

Primary

Measure	Time frame	Description
lumen area	1 day	lumen area cut-off that can predict the functional significance of a lesion

Secondary

Measure	Time frame	Description
angiographic stenosis, % plaque area	1 day	angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
CT measurement	1 day	Diagnostic accuracy of CT derived parameters

Countries

South Korea

Contacts

Primary ContactBon-kwon Koo, MD/PhD

bkkoo@snu.ac.kr82-2-2072-2062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026