Comparison of Fractional Flow Reserve and Intravascular Ultrasound

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Keimyung University
Inje University
Ajou University
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01133015
First received: May 24, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Device: Fractional flow reserve
Device: IVUS
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • lumen area [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    lumen area cut-off that can predict the functional significance of a lesion


Secondary Outcome Measures:
  • angiographic stenosis, % plaque area [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions

  • CT measurement [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Diagnostic accuracy of CT derived parameters


Estimated Enrollment: 191
Study Start Date: March 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermediate lesion
Intermediate lesion will be evaluated by both IVUS and FFR
Device: Fractional flow reserve
Fractional flow reserve measured by pressure wire
Other Name: RADI pressure wire
Device: IVUS
intravascular ultrasound
Other Name: Volcano IVUS, boston scientific

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%.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133015

Contacts
Contact: Bon-kwon Koo, MD/PhD 82-2-2072-2062 bkkoo@snu.ac.kr

Locations
Korea, Republic of
Seoul national university hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bon-kown Koo, MD/PhD    82-2-2072-2062    bkkoo@snu.ac.kr   
Principal Investigator: Bon-kwon Koo, MD/PhD         
Sponsors and Collaborators
Seoul National University Hospital
Keimyung University
Inje University
Ajou University
Investigators
Principal Investigator: Bon-kwon Koo, MD/PhD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bon-Kwon Koo / Professor, Seoul National University hospital
ClinicalTrials.gov Identifier: NCT01133015     History of Changes
Other Study ID Numbers: 1001-009-305
Study First Received: May 24, 2010
Last Updated: July 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
FFR
IVUS
MLA

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014