Comparison of Fractional Flow Reserve and Intravascular Ultrasound
1 other identifier
interventional
191
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJuly 21, 2011
July 1, 2011
2.7 years
May 24, 2010
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lumen area
lumen area cut-off that can predict the functional significance of a lesion
1 day
Secondary Outcomes (2)
angiographic stenosis, % plaque area
1 day
CT measurement
1 day
Study Arms (1)
Intermediate lesion
EXPERIMENTALIntermediate lesion will be evaluated by both IVUS and FFR
Interventions
Fractional flow reserve measured by pressure wire
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Keimyung Universitycollaborator
- Inje Universitycollaborator
- Ajou Universitycollaborator
Study Sites (1)
Seoul national university hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 21777890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bon-kwon Koo, MD/PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 28, 2010
Study Start
March 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
July 21, 2011
Record last verified: 2011-07