Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

August 10, 2011 updated by: Seoul National University Hospital

Comparison of Fractional Flow Reserve (FFR) and Minimal Luminal Area (MLA) by Intravascular Ultrasound (IVUS) in Evaluating Intermediate Coronary Artery Stenosis: International Multi-center Study

Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Study Overview

Status

Unknown

Conditions

Detailed Description

Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate coronary stenosis who underwent both FFR and IVUS

Description

Inclusion Criteria:

  • Intermediate coronary stenosis by visual estimation

Exclusion Criteria:

  • history of coronary artery bypass graft surgery
  • previously revascularized lesion
  • creatinine > 1.6 mg/dL or eGFR < 30 ml/min/1.73m2 pre-procedure per institutional standards
  • known pregnancy
  • 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

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
intermediate lesion
intermediate lesions evaluated by both IVUS and FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lumen area
Time Frame: day 1
lumen area cut-off that can predict functional significance of a lesion
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic stenosis, % plaque area
Time Frame: day 1
angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
day 1

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

University of Florida
Asan Medical Center
Medstar Health Research Institute
Inje University
National University, Singapore
Keimyung University

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

March 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2011

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1106-077-366

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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