Coronary Artery DiseasePROBE-FFRNCT05716997
Relationship Between Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 2 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 43 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Dec 2022to 31 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Ewha Womans University Mokdong Hospital
Seoul
Seou National University Hospital
Seoul
About this study
Official title: A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR
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
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 year
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
Measured: 1 year
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)
Measured: 1 year
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)
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Dec 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ewha Womans University Mokdong Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, Study chair, Seoul National University HospitalBon-Kwon Koo, MD, Study director, Seoul National University HospitalBon-Kwon Koo, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716997
- Sponsor's protocol ID
- PROBE-FFR
- Acronym
- PROBE-FFR
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR
- ClinicalTrials.gov ID
- NCT05716997
- Acronym / sponsor ID
- PROBE-FFR / PROBE-FFR
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Fractional flow reserve, Balloon angioplasty, Coronary artery dissection, Coronary artery elastic recoil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ewha Womans University Mokdong Hospital
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty
Time frame: 15 minutes
Coronary angiographic findings and fractional flow within 15 minutes after coronary balloon angioplasty are collected and analyzed.
6 secondary outcomes
Comparison of differences in fractional flow reserve (FFR) before and after lesions between coronary balloon angioplasty using a scoring balloon and a regular balloon
Time frame: 1 year
1-year outcome
Time frame: 1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific minimum lumen area
Time frame: 1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific plaque burden
Time frame: 1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific positive remodeling
Time frame: 1 year
Relationship between fractional blood flow reserve and intravascular ultrasound lesion-specific attenuated plaque
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Kwon Koo, MD study chair
Seoul National University Hospital
Bon-Kwon Koo, MD study director
Seoul National University Hospital
Bon-Kwon Koo, MD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in fractional flow reserve (FFR) according to angiographic findings after coronary artery balloon angioplasty (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.