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NCT07539324Recruiting

Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD

Clinical Impact of Drug-Coated-Balloon-based Versus Drug-Eluting-Stent-based Intervention in Patients With Multivessel Coronary Artery Disease : A Prospective, Multicenter, Active-controlled, Randomized, Single-blind, Investigator-initiated Clinical Trial

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

This study aimes to compare the clinical outcomes of drug-coated balloon-based percutaneous coronary intervention (DCB-based PCI) and drug-eluting stent-based percutaneous coronary intervention (DES-based PCI) in patients with multivessel coronary artery lesions measuring 2.25 mm to 4.0 mm in diameter through a prospective, multicenter, active-controlled, randomized, investigator-initiated clinical trial.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
892 (estimated)
First submitted
13 Apr 2026
Start date
28 Sept 2026
Primary completion date
31 Dec 2030
Lead sponsor
Genoss Co., Ltd.
NCT number
NCT07539324

What you commit to

  • Study type: Interventional
  • Planned participants: 892
  • From 28 Sept 2026 to the primary completion date, 31 Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Life expectancy of ≤2 years due to concomitant medical conditions.

Other illness

  • Known hypersensitivity or allergy to contrast media, L-605 cobalt-chromium (Co-Cr) alloy, PLA or PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
  • Patients in whom the investigator determines that PCI cannot be performed because of the anatomical characteristics of the target vessel or lesion or the patient's clinical condition.

Other

  • Patients meeting any of the following criteria will be excluded from enrollment.
  • Cardiogenic shock or the need for mechanical or pharmacological circulatory support.
  • Current participation in, or planned participation in, another interventional clinical trial, excluding observational studies.
  • Pregnant women or women of childbearing potential.
  • A target lesion located within a saphenous vein graft or an arterial graft.

Who the study is looking for

  • Patients must meet all of the following inclusion criteria to be eligible for participation in this clinical study.
  • Adults aged ≥20 years with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
  • Patients with ST-segment elevation myocardial infarction (STEMI) who have undergone successful and uncomplicated primary percutaneous coronary intervention (PCI), are at least 48 hours after the index procedure, and have no evidence of thrombus in the lesion(s) intended for treatment.
  • Patients with multivessel coronary artery disease, defined as ≥50% diameter stenosis by coronary angiography, in whom the investigator determines that PCI is indicated in at least two major epicardial coronary arteries.
  • Patients with a reference vessel diameter (RVD) of ≥2.25 mm and ≤4.0 mm, as assessed by coronary angiography.
  • Patients in whom the investigator determines, based on coronary angiographic findings and clinical assessment, that PCI of the target lesion(s) is technically feasible.
  • Patients who voluntarily provide written informed consent to participate in the clinical trial and are willing and able to comply with the study requirements.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ulsan University Hospital
Coordinator of this site? Confirm its status
UlsanSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.