Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
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
  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 ] [ Designated as safety issue: No ]
    lumen area cut-off that can predict functional significance of a lesion


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014