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Main Branch Versus Side Branch Ostial Lesion

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01335659
First received: April 7, 2011
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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


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

Study Type: Observational
Study Design: 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

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 at ostial lesion


Secondary Outcome Measures:
  • angiographic stenosis, % plaque area [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.


Enrollment: 77
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335659

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: 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: NCT01335659     History of Changes
Other Study ID Numbers: Bif_3
Study First Received: April 7, 2011
Last Updated: July 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
FFR
IVUS
QCA

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

ClinicalTrials.gov processed this record on May 21, 2013