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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07442500

Acronym

DCB_DES

Enrollment

470000

Registered

2026-03-02

Start date

2026-02-28

Completion date

2026-12-31

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

Keywords

Drug coated balloon, Drug-eluting stent, High bleeding risk

Brief summary

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.

Interventions

DEVICEDrug coated balloon

Patients receiving drug coated balloon angioplasty for de novo coronary artery disease

DEVICEDrug-eluting stent

Patients receiving drug-eluting stent implantationfor de novo coronary artery disease

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORKi Hong Choi, MD, PhD

Samsung Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026