Main Branch Versus Side Branch Ostial Lesion

July 20, 2011 updated by: Seoul National University Hospital

Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

77

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lumen area
Time Frame: 1 day
lumen area at ostial lesion
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Bon-kwon Koo, MD/PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (ESTIMATE)

April 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bif_3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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