Comparison of Fractional Flow Reserve and Intravascular Ultrasound

Coronary Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01133015
• Other study ID #: 1001-009-305
• Status: Recruiting
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: July 20, 2011
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: Bon-kwon Koo, MD/PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 191
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• Fractional flow reserve
Fractional flow reserve measured by pressure wire
• IVUS
intravascular ultrasound

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ajou University, Inje University, Keimyung University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lumen area	lumen area cut-off that can predict the functional significance of a lesion	1 day	No
Secondary	angiographic stenosis, % plaque area	angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions	1 day	No
Secondary	CT measurement	Diagnostic accuracy of CT derived parameters	1 day	No