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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05716997
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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)
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 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

Trial Locations

Locations (2)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Seou National University Hospital; 🇰🇷 Seoul, Korea, Republic of