NCT05716997Completed
Relationship Between Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty
A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 43 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 20 Dec 2022
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05716997
What you commit to
- Study type: Observational
- Participants enrolled: 43
- From 20 Dec 2022 to the primary completion date, 31 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass surgery
Other illness
- Clinically unstable or ST-segment elevation myocardial infarction
- Myocardial infarction in the region supplied by the target vessel
- Accompanying primary valve disease requiring treatment
- Accompanying primary heart disease such as dilated cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathy
- Congenital heart disease
Lab values
- Left ventricular ejection fraction (EF) less than 30%
- Most recently measured eGFR is less than 30 right before the procedure
Other
- 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
- 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)
Who the study is looking for
- 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.
Age in the registry: 19 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seou National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.