Prospective CT Assessment After DCB (PREVAIL)

Seoul National University

Status: Enrolling

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07373145

H-2404-105-1532

ERP-2024-13777 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

This prospective, multicenter observational cohort study will include patients with coronary artery disease who underwent drug-coated balloon (DCB) treatment and had coronary computed tomography angiography (CCTA) performed at baseline. Follow-up CCTA will be conducted two years after the index DCB procedure. The study aims to evaluate changes in target lesion hemodynamic parameters, diameter stenosis, and plaque characteristics on CCTA before and after DCB treatment, and to assess their association with subsequent clinical outcomes.

Enrollment: 165 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

165 participants in 1 patient group

Patients treated with a drug-coated balloon for de novo lesions.

Description:

Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA.