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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01414361

Enrollment

1000

Registered

2011-08-11

Start date

2009-03-31

Completion date

2011-11-30

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Stenosis

Keywords

Coronary artery stenosis, Fractional flow reserve, Intravascular ultrasonography

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
lumen area	day 1	lumen area cut-off that can predict functional significance of a lesion

Secondary

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

Countries

South Korea

Contacts

Primary ContactBon-Kwon Koo, MD/PhD

bkkoo@snu.ac.kr82-2-2072-2062

Outcome results