Prospective CT Assessment After DCB | NCT07373145

Studies
Prospective CT Assessment After DCB

NCT07373145

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

165Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ERP-2024-13777	Other Grant/Funding Number	Medtronic

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Aug 1, 2031Estimated

Completion Date

Dec 1, 2032Estimated

First Submitted Date

Aug 8, 2025

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 28, 2026Actual

Name	Class
Ulsan University Hospital	OTHER
National Health Insurance Service Ilsan Hospital	OTHER
KangWon National University Hospital	OTHER
Korea University Guro Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

165Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The sharing plan will be decided by the study committee.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases