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Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

This study is currently recruiting participants.
Verified August 2011 by Seoul National University Hospital
Sponsor:
Collaborators:
Inje University
Keimyung University
Asan Medical Center
Washington Hospital Center
University of Florida
National University, Singapore
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01414361
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
History of Changes

August 9, 2011
August 10, 2011
March 2009
November 2011   (final data collection date for primary outcome measure)
lumen area [ Time Frame: day 1 ] [ Designated as safety issue: No ]
lumen area cut-off that can predict functional significance of a lesion
Same as current
Complete list of historical versions of study NCT01414361 on ClinicalTrials.gov Archive Site
angiographic stenosis, % plaque area [ Time Frame: day 1 ] [ Designated as safety issue: No ]
angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
Same as current
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Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Patients with intermediate coronary stenosis who underwent both FFR and IVUS
Coronary Artery Stenosis
Not Provided
intermediate lesion
intermediate lesions evaluated by both IVUS and FFR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bon-Kwon Koo, MD/PhD 82-2-2072-2062 bkkoo@snu.ac.kr
Korea, Republic of
 
NCT01414361
H-1106-077-366
No
Division of cardiology / Cardiovascular center, Seoul National University Hospital
Seoul National University Hospital
  • Inje University
  • Keimyung University
  • Asan Medical Center
  • Washington Hospital Center
  • University of Florida
  • National University, Singapore
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
Seoul National University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP