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Not yet recruiting NCT07442500

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

— Observational Coronary Artery Disease Percutaneous Coronary Intervention (PCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug coated balloon, Drug-eluting stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention (PCI). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Drug coated balloon
    Patients receiving drug coated balloon angioplasty for de novo coronary artery disease
  • Device Drug-eluting stent
    Patients receiving drug-eluting stent implantationfor de novo coronary artery disease

Primary outcome measures

  • Rates of MACCE (major adverse cardiac and cerebrovascular events) [Time frame: 3 years after index procedure]
Secondary outcome measures (6)
  • Rates of Major bleeding [Time frame: 3 years after index procedure]
  • Rates of NACE (net adverse clinical events) [Time frame: 3 years after index procedure]
  • Rates of all-cause death [Time frame: 3 years after index procedure]
  • Rates of myocardial infarction [Time frame: 3 years after index procedure]
  • Rates of revascularization [Time frame: 3 years after index procedure]
  • Rates of stroke [Time frame: 3 years after index procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07442500 · DCB_DES

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗