NCT06104033

Brief Summary

This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress88%
Sep 2023Oct 2026

Study Start

First participant enrolled

September 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Coronary Artery DiseaseMulti Vessel Coronary Artery Disease

Keywords

Coronary artery diseaseMultivessel coronary artery diseasePercutaneous coronary interventionDrug-coated balloonDrug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • The reclassification rate of the treatment strategy

    The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.

    At the time of procedure

Secondary Outcomes (18)

  • Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy

    At the time of procedure

  • Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy

    At the time of procedure

  • Cardiovascular death

    1 year

  • All-cause death

    1 year

  • Non-fatal myocardial infarction (MI)

    1 year

  • +13 more secondary outcomes

Study Arms (2)

Hybrid strategy

The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.

Device: drug-coated balloonDevice: drug-eluting stent

DES only

The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.

Device: drug-eluting stent

Interventions

drug-coated balloonDEVICE

For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.

Hybrid strategy
drug-eluting stentDEVICE

When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.

DES onlyHybrid strategy

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multivessel coronary artery disease who undergo coronary intervention

You may qualify if:

  • Age 19 or older
  • Multivessel coronary artery disease patients requiring coronary intervention
  • Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
  • Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
  • Capable of understanding the risks and benefits of participating in the study and providing informed consent

You may not qualify if:

  • Incapable of voluntarily providing informed consent
  • Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
  • Cardiogenic shock or cardiac arrest patients
  • Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
  • Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
  • Patients with severe valvular heart disease requiring open heart surgery
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bon-Kwon Koo

Seoul, South Korea

RECRUITING

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

  • Bon-Kwon Koo, MD, PhD

    +82-2-2072-2062

    STUDY CHAIR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

+82-2-2072-2062bkkoo@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

September 18, 2023

Primary Completion

August 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

KR(1)