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

NCT05716997 | Completed DMC

• 1 other identifier: PROBE-FFR
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

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

Keywords

Coronary artery disease; Fractional flow reserve; Balloon angioplasty; Coronary artery dissection; Coronary artery elastic recoil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 1-year outcome

  1 year

• 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 plaque burden

  1 year

• Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling

  1 year

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: collaborator
• Seoul National University Hospital: lead

Study Sites (2)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Seou National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bon-Kwon Koo, MD

  Seoul National University Hospital

  STUDY CHAIR

• Bon-Kwon Koo, MD

  Seoul National University Hospital

  STUDY DIRECTOR

• Bon-Kwon Koo, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: December 20, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

KR (2)