Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

• Conditions: Coronary Artery Stenosis

• Registration Number: NCT01414361
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Intermediate coronary stenosis by visual estimation

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lumen area	day 1	lumen area cut-off that can predict functional significance of a lesion

Secondary Outcome Measures

Name	Time	Method
angiographic stenosis, % plaque area	day 1	angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of