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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05716997

Collaborator

Ewha Womans University Mokdong Hospital (Other)

100

Enrollment

Locations

24.4

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty [15 minutes]
Coronary angiographic findings and fractional flow within 15 minutes after coronary balloon angioplasty are collected and analyzed.

Secondary Outcome Measures

Comparison of differences in fractional flow reserve (FFR) before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon [1 year]
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 outcome [1 year]
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
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area [1 year]
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area (mm2)
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific plaque burden [1 year]
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)
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling [1 year]
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
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific attenuated plaque [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 120 Years

Sexes Eligible for Study:

All

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