NCT07442500

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 24, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Coronary Artery DiseasePercutaneous Coronary Intervention (PCI)

Keywords

Drug coated balloonDrug-eluting stentHigh bleeding risk

Outcome Measures

Primary Outcomes (1)

  • Rates of MACCE (major adverse cardiac and cerebrovascular events)

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

    3 years after index procedure

Secondary Outcomes (6)

  • Rates of Major bleeding

    3 years after index procedure

  • Rates of NACE (net adverse clinical events)

    3 years after index procedure

  • Rates of all-cause death

    3 years after index procedure

  • Rates of myocardial infarction

    3 years after index procedure

  • Rates of revascularization

    3 years after index procedure

  • +1 more secondary outcomes

Study Arms (2)

Drug coated balloon

Patients receiving drug coated balloon angioplasty

Device: Drug coated balloon

Drug-eluting stent

Patients receiving drug-eluting stent implantation

Device: Drug-eluting stent

Interventions

Drug coated balloonDEVICE

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

Drug coated balloon
Drug-eluting stentDEVICE

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

Drug-eluting stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Ki Hong Choi, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

KR(1)