Relationship Between Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty

NCT ID: NCT05716997

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2026-01-31

Brief Summary

The goal of this prospective observational study is to learn about in patients who need percutaneous coronary intervention for coronary artery disease. The main questions it aims to answer are:

• Fractional flow reserve according to coronary angiography findings after coronary artery balloon angioplasty
• Differences in fractional blood flow reserve before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon Participants will voluntarily consent to the study after being fully informed about the study and given ample opportunity to ask questions.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with clinically stable coronary artery disease
• Patients undergoing balloon angioplasty as an interventional procedure (FFR-guided PCI) using coronary artery fractional blood flow reserve for de novo lesions with a standard vessel diameter of 2.25 mm or more under percutaneous coronary angiography (hereafter referred to as coronary angiography)

(Note) If there are other lesions in the proximal area and the FFR of the distal lesion is collected, it is included in the selection target regardless of whether or not the proximal lesion was operated on.

Exclusion Criteria

• Target lesion with stenosis of less than 50% or greater than 90% of the internal diameter
• Procedure for restenosis within the stent
• Pre-dilation performed on the target lesion before the coronary artery fractional blood flow reserve test
• Prior coronary artery bypass surgery
• Clinically unstable or ST-segment elevation myocardial infarction
• Myocardial infarction in the region supplied by the target vessel
• Target vessel is a blood vessel that supplies collateral circulation for occlusion of other blood vessels (not applicable when the need for collateral circulation has been resolved due to the opening of another vessel occlusion)
• Left ventricular ejection fraction (EF) less than 30%
• Most recently measured eGFR is less than 30 right before the procedure
• Accompanying primary valve disease requiring treatment
• Accompanying primary heart disease such as dilated cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathy
• Congenital heart disease

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bon-Kwon Koo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bon-Kwon Koo, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Bon-Kwon Koo, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Bon-Kwon Koo, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Seou National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PROBE-FFR

Identifier Type: -

Identifier Source: org_study_id