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Main Branch Versus Side Branch Ostial Lesion

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ClinicalTrials.gov Identifier: NCT01335659
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : July 21, 2011
Information provided by:

Study Description
Brief Summary:
The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Condition or disease Intervention/treatment
Coronary Artery Stenosis Device: Fractional flow reserve Device: IVUS

Detailed Description:
Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Study Design

Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions
Study Start Date : June 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
ostial lesion
ostial lesion will be evaluated by IVUS and FFR
Device: Fractional flow reserve
Fractional flow reserve measured by pressure wire
Other Name: Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden)
Device: IVUS

intravascular ultrasound

:IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter

Other Name: iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)

Outcome Measures

Primary Outcome Measures :
  1. lumen area [ Time Frame: 1 day ]
    lumen area at ostial lesion

Secondary Outcome Measures :
  1. angiographic stenosis, % plaque area [ Time Frame: 1 day ]
    angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH

Inclusion Criteria:

  • Age 21-85
  • Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:
  • Previous catheterization with any coronary ostium lesion 50% or greater
  • 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
  • left main coronary ostial lesion
  • significant stenosis at proximal or distal part of coronary ostium lesion
  • ostial lesion related to infarcton
  • Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
  • Ejection fraction lower than 40%
  • Known Pregnancy
  • Arrhythmia
  • Contrast agent allergy that cannot be adequately premedicated
  • 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335659

Sponsors and Collaborators
Seoul National University Hospital
Study Director: Bon-kwon Koo, MD/PhD Seoul National University Hospital
More Information

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: NCT01335659     History of Changes
Other Study ID Numbers: Bif_3
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases