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Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414361
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Inje University
Keimyung University
Asan Medical Center
Washington Hospital Center
University of Florida
National University, Singapore
Information provided by:
Seoul National University Hospital
  Purpose
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.

Condition Phase
Coronary Artery Stenosis Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • lumen area [ Time Frame: day 1 ]
    lumen area cut-off that can predict functional significance of a lesion


Secondary Outcome Measures:
  • angiographic stenosis, % plaque area [ Time Frame: day 1 ]
    angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions


Estimated Enrollment: 1000
Study Start Date: March 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
intermediate lesion
intermediate lesions evaluated by both IVUS and FFR

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with intermediate coronary stenosis who underwent both FFR and IVUS
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01414361


Contacts
Contact: Bon-Kwon Koo, MD/PhD 82-2-2072-2062 bkkoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bon-Kwon Koo, MD/PhD    82-2-2072-2062    bkkoo@snu.ac.kr   
Principal Investigator: Bon-Kwon Koo, MD/PhD         
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Keimyung University
Asan Medical Center
Washington Hospital Center
University of Florida
National University, Singapore
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
  More Information

Responsible Party: Division of cardiology / Cardiovascular center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01414361     History of Changes
Other Study ID Numbers: H-1106-077-366
First Submitted: August 9, 2011
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by Seoul National University Hospital:
Coronary artery stenosis
Fractional flow reserve
Intravascular ultrasonography

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases