Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

Coronary Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01414361
• Other study ID #: H-1106-077-366
• Status: Recruiting
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: August 10, 2011
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD/PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Stenosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Inje University, Keimyung University, National University, Singapore, University of Florida, Washington Hospital Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lumen area	lumen area cut-off that can predict functional significance of a lesion	day 1	No
Secondary	angiographic stenosis, % plaque area	angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions	day 1	No