Comparison of Fractional Flow Reserve and Intravascular Ultrasound

NCT ID: NCT01133015

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-11-30

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%.

Conditions

Coronary Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intermediate lesion

Intermediate lesion will be evaluated by both IVUS and FFR

Group Type: EXPERIMENTAL

Fractional flow reserve

Intervention Type: DEVICE

Fractional flow reserve measured by pressure wire

IVUS

Intervention Type: DEVICE

intravascular ultrasound

Interventions

Fractional flow reserve

Fractional flow reserve measured by pressure wire

Intervention Type: DEVICE

IVUS

intravascular ultrasound

Intervention Type: DEVICE

Other Intervention Names

RADI pressure wire; Volcano IVUS, boston scientific

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keimyung University

OTHER

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Ajou University

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University hospital

Principal Investigators

Bon-kwon Koo, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul national university hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Bon-kwon Koo, MD/PhD

Role: CONTACT

bkkoo@snu.ac.kr

82-2-2072-2062

Facility Contacts

Bon-kown Koo, MD/PhD

Role: primary

bkkoo@snu.ac.kr

82-2-2072-2062

References

Koo BK, Yang HM, Doh JH, Choe H, Lee SY, Yoon CH, Cho YK, Nam CW, Hur SH, Lim HS, Yoon MH, Park KW, Na SH, Youn TJ, Chung WY, Ma S, Park SK, Kim HS, Tahk SJ. Optimal intravascular ultrasound criteria and their accuracy for defining the functional significance of intermediate coronary stenoses of different locations. JACC Cardiovasc Interv. 2011 Jul;4(7):803-11. doi: 10.1016/j.jcin.2011.03.013.

Reference Type: DERIVED

PMID: 21777890 (View on PubMed)

Other Identifiers

1001-009-305

Identifier Type: -

Identifier Source: org_study_id