Prospective CT Assessment After DCB

NCT07373145 | Recruiting DMC

• 2 other identifiers: H-2404-105-1532ERP-2024-13777
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

drug coated balloon; CCTA; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Changes in ΔFFR CT before and after DCB procedure

  From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Secondary Outcomes (2)

• Changes in plaque characteristics before and after DCB procedure

  From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

• Changes in diameter stenosis before and after DCB procedure

  From baseline CCTA to follow-up CCTA performed 2 years after the index PCI

Study Arms (1)

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

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who took coronary computed tomography angiography (CCTA) and received drug-coated balloon (DCB) treatment for coronary artery disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ulsan University Hospital: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• KangWon National University Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Sejong General Hospital: collaborator
• Hanyang University Seoul Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Bon-kwon Koo, MD, PhD

CONTACT

82-2-2072-2062; bkkoo@snu.ac.kr

Junpil Yun, MD

CONTACT

82-10-8001-9969; junpilyun@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: January 28, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

KR (1)