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Comparison of Fractional Flow Reserve and Intravascular Ultrasound

Primary Purpose

Coronary Artery Stenosis

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fractional flow reserve
IVUS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Stenosis focused on measuring FFR, IVUS, MLA

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul national university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermediate lesion

Arm Description

Intermediate lesion will be evaluated by both IVUS and FFR

Outcomes

Primary Outcome Measures

lumen area
lumen area cut-off that can predict the functional significance of a lesion

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2010
Last Updated
July 20, 2011
Sponsor
Seoul National University Hospital
Collaborators
Keimyung University, Inje University, Ajou University
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1. Study Identification

Unique Protocol Identification Number
NCT01133015
Brief Title
Comparison of Fractional Flow Reserve and Intravascular Ultrasound
Official Title
Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Keimyung University, Inje University, Ajou University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
FFR, IVUS, MLA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
191 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate lesion
Arm Type
Experimental
Arm Description
Intermediate lesion will be evaluated by both IVUS and FFR
Intervention Type
Device
Intervention Name(s)
Fractional flow reserve
Other Intervention Name(s)
RADI pressure wire
Intervention Description
Fractional flow reserve measured by pressure wire
Intervention Type
Device
Intervention Name(s)
IVUS
Other Intervention Name(s)
Volcano IVUS, boston scientific
Intervention Description
intravascular ultrasound
Primary Outcome Measure Information:
Title
lumen area
Description
lumen area cut-off that can predict the functional significance of a lesion
Time Frame
1 day
Secondary Outcome Measure Information:
Title
angiographic stenosis, % plaque area
Description
angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
Time Frame
1 day
Title
CT measurement
Description
Diagnostic accuracy of CT derived parameters
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bon-kwon Koo, MD/PhD
Phone
82-2-2072-2062
Email
bkkoo@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-kwon Koo, MD/PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bon-kown Koo, MD/PhD
Phone
82-2-2072-2062
Email
bkkoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Bon-kwon Koo, MD/PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21777890
Citation
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.
Results Reference
derived

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Comparison of Fractional Flow Reserve and Intravascular Ultrasound

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