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Recruiting NCT05716997

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

Conditions: Coronary Artery Disease

Sex: All
Ages: 19 Years – 120 Years
Enrollment: 100
Sponsor: Seoul National University Hospital

Location: Korea, Republic of

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 angioplastyDifferences 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.

Eligibility Criteria

Inclusion Criteria:Patients with clinically stable coronary artery diseasePatients 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 diameterProcedure for restenosis within the stentPre-dilation performed on the target lesion before the coronary artery fractional blood flow reserve testPrior coronary artery bypass surgeryClinically unstable or ST-segment elevation myocardial infarctionMyocardial infarction in the region supplied by the target vesselTarget 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 procedureAccompanying primary valve disease requiring treatmentAccompanying primary heart disease such as dilated cardiomyopathy, hypertrophic cardiomyopathy, or restrictive cardiomyopathyCongenital heart disease

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05716997). StuddyBuddy aggregates publicly available trial information.