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Prospective CT Assessment After DCB
RECRUITINGSponsored by Seoul National University Hospital
Actively Recruiting
SponsorSeoul National University Hospital
Started2025-08-01
Est. completion2031-08-01
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07373145
Summary
This prospective, multicenter observational cohort study aims to investigate changes in target lesion hemodynamic parameters, diameter stenosis, plaque characteristics of CCTA before and after the DCB procedure and evaluate their association with clinical outcomes.
Eligibility
Age: 19 Years+Healthy volunteers accepted
Inclusion Criteria: * Patients with Age ≥ 19 * Patients who took CCTA and were found to have coronary artery disease requiring reperfusion * Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA. * The target lesion is a de novo lesion with a vessel diameter between 2.25mm and 3.00mm * Patients deemed suitable for coronary intervention using drug-coated balloon by clinical assessment * Patients who have been adequately informed about this study and have voluntarily provided written consent to participate. Exclusion Criteria: * The target lesion is an in-stent restenosis lesion * Patient requiring emergency salvage stenting in target lesion * Patients with a stent previously implanted in the same vessel * Lesions involving chronic total occlusion or prior coronary artery bypass grafting (CABG). * Patients with eGFR (estimated glomerular filtration rate) \< 45 ml/min/1.73mm2 * Patients with coronary artery calcium score ≥ 1000 as determined by CCTA * Patients with an expected survival of less than 5 years * Pregnant or breastfeeding patients * Patients deemed inappropriate to participate in this study based on the judgment of study investigators
Conditions2
Coronary Artery DiseaseHeart Disease
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Actively Recruiting
SponsorSeoul National University Hospital
Started2025-08-01
Est. completion2031-08-01
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07373145