Relationship Between Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty (PROBE-FFR)

A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Ewha Womans University Mokdong Hospital
  • Seoul, South Korea
    • Seou National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who met the inclusion criteria and underwent interventions, as determined by clinical necessity, using fractional blood flow reserve (FFR) after percutaneous coronary angiography (PCA) will be included in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty	Coronary angiographic findings and fractional flow within 15 minutes after coronary balloon angioplasty are collected and analyzed.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of differences in fractional flow reserve (FFR) before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon	Determine whether a scoring balloon or a general balloon was used during balloon angioplasty, and analyze whether there is a difference in FFR depending on the balloon used.	1 year
1-year outcome	Relationship between major cardiac events within 1 year according to changes in pre- and post-lesional fractional flow reserve (FFR), steady-state pressure ratio, and quantitative flow analysis (QFR) values before and after coronary artery balloon angioplasty	1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area	Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area (mm2)	1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific plaque burden	Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific plaque burden (plaque burden = plaque cross-sectional area (CSA, mm2)+ media CSA / external elastic membrane CSA)	1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling	Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling (remodeling ratio > 1.05). remodeling ratio (RR) = external elastic membrane (EEM) area lesion/EEM area proximal reference	1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific attenuated plaque	Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific attenuated plaque Attenuated Plaque: Plaque seen in intravascular ultrasound with acoustic shadowing behind large, echolucent acute culprit lesion sites, in the absence of bright calcium.	1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ewha Womans University Mokdong Hospital
• Investigators: Study Chair: Bon-Kwon Koo, MD, Seoul National University Hospital; Study Director: Bon-Kwon Koo, MD, Seoul National University Hospital; Principal Investigator: Bon-Kwon Koo, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; Fractional flow reserve; Balloon angioplasty; Coronary artery dissection; Coronary artery elastic recoil
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: PROBE-FFR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No