Examining the link between coronary angiography results and blood flow after balloon angioplasty
A PRospective Observational Study on the Relationship BEtween Coronary Angiography Findings and Fractional Flow Reserve After Balloon Angioplasty: PROBE-FFR
This study is testing how well different types of balloons used in angioplasty improve blood flow in patients with coronary artery disease by looking at heart imaging results before and after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 120 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05716997 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate patients with coronary artery disease who require balloon angioplasty. It focuses on understanding the relationship between fractional flow reserve (FFR) measurements and coronary angiography findings before and after the procedure. The study will compare FFR outcomes using different types of balloons during the angioplasty process. Participants will provide informed consent and will be monitored for their FFR results post-intervention.
Who should consider this trial
Good fit: Ideal candidates include patients with stable coronary artery disease undergoing balloon angioplasty for de novo lesions.
Not a fit: Patients with unstable coronary conditions or those requiring bypass surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of optimal angioplasty techniques, potentially improving patient outcomes in coronary artery disease.
How similar studies have performed: Previous studies have shown promising results in understanding the relationship between angiography findings and FFR, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 1 other locations
- Ewha Womans University Mokdong Hospital — Seoul, Korea, Republic of (Recruiting)
- Seou National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Bon-Kwon Koo, MD — Seoul National University Hospital
- Study coordinator: Bon-Kwon Koo, MD
- Email: bkkoo@snu.ac.kr
- Phone: +82-1033561869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.