Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

Seoul National University

Status: Unknown

Conditions: Coronary Artery Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01414361

H-1106-077-366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

intermediate lesion

Description:

intermediate lesions evaluated by both IVUS and FFR