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NCT Number: NCT07442500

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention (PCI) Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location contact

Ki Hong Choi

CONTACT

01088751648

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug coated balloon

Device

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

Drug-Eluting Stent

Device

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

Primary outcomes

  1. Rates of MACCE (major adverse cardiac and cerebrovascular events)

    Time frame: 3 years after index procedure

    all-cause death, myocardial infarction, revascularization, and stroke

Secondary outcomes

  1. Rates of Major bleeding

    Time frame: 3 years after index procedure

    major bleeding requiring transfusion

  2. Rates of NACE (net adverse clinical events)

    Time frame: 3 years after index procedure

    MACCE and any major bleeding requiring transfusion

  3. Rates of all-cause death

    Time frame: 3 years after index procedure

    death from any causes

  4. Rates of myocardial infarction

    Time frame: 3 years after index procedure

  5. Rates of revascularization

    Time frame: 3 years after index procedure

    repeat revascularization

  6. Rates of stroke

    Time frame: 3 years after index procedure

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: DCB_DES

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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