Clinical trial NCT01414361: Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Stenosis
Keywords: Coronary artery stenosis
Fractional flow reserve
Intravascular ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University
name: Keimyung University
name: Asan Medical Center
name: Medstar Health Research Institute
name: University of Florida
name: National University of Singapore
First posted: 2011-08-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate coronary stenosis who underwent both FFR and IVUS

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.

Eligibility 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

Primary outcomes:
measure: lumen area
timeFrame: day 1
Secondary outcomes:
measure: angiographic stenosis, % plaque area
timeFrame: day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: