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

Coronary Artery Disease Clinical Trial

— PROBE-FFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716997
• Other study ID #: PROBE-FFR
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD
• Phone: +82-1033561869
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Seou National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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