Researchers watch how blood flow changes after heart artery balloon treatment
NCT ID NCT05716997
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed observational study looked at 43 patients with stable coronary artery disease who had balloon angioplasty. Researchers measured blood flow (fractional flow reserve) right after the procedure and compared it with angiographic images. They also compared two types of balloons—scoring and regular—to see if they affected blood flow differently. The study aimed to better understand how balloon treatment impacts heart artery function.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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43 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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19 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ewha Womans University Mokdong Hospital
Seoul, South Korea
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Seou National University Hospital
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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