Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease (DCB_DES)

February 24, 2026 updated by: Ki Hong Choi, Samsung Medical Center
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

470000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
        • Contact:
          • Ki Hong Choi
          • Phone Number: 01088751648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention

Description

Inclusion Criteria:

  • Patients with coronary artery disease undergoing percutaneous coronary intervention
  • Used devices number less than three (relatively simple lesion)

Exclusion Criteria:

  • Hybrid strategy (DCB and DES use)
  • Failed percutaneous coronary intervention
  • Previous revascularization procedure before index percutaneous coronary intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Drug coated balloon
Patients receiving drug coated balloon angioplasty
Device: Drug coated balloon
Patients receiving drug coated balloon angioplasty for de novo coronary artery disease
Drug-eluting stent
Patients receiving drug-eluting stent implantation
Device: Drug-eluting stent
Patients receiving drug-eluting stent implantationfor de novo coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of MACCE (major adverse cardiac and cerebrovascular events)
Time Frame: 3 years after index procedure
all-cause death, myocardial infarction, revascularization, and stroke
3 years after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Major bleeding
Time Frame: 3 years after index procedure
major bleeding requiring transfusion
3 years after index procedure
Rates of NACE (net adverse clinical events)
Time Frame: 3 years after index procedure
MACCE and any major bleeding requiring transfusion
3 years after index procedure
Rates of all-cause death
Time Frame: 3 years after index procedure
death from any causes
3 years after index procedure
Rates of myocardial infarction
Time Frame: 3 years after index procedure
3 years after index procedure
Rates of revascularization
Time Frame: 3 years after index procedure
repeat revascularization
3 years after index procedure
Rates of stroke
Time Frame: 3 years after index procedure
3 years after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Ki Hong Choi, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCB_DES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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