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
  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 April 17, 2014