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NCT Number: NCT07539324

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

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.

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Key information

Conditions

Multi Vessel Coronary Artery Disease Percutaneous Coronary Intervention

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a prospective, multicenter, active-controlled, randomized, single-blind, investigator-initiated clinical trial in patients with multivessel coronary artery disease.

The clinical outcomes of the DCB-based PCI group and the DES-based PCI group, assigned through 1:1 random assignment, will be compared, and approximately 9 hospitals will participate.

The primary endpoint is the Net Clinical Outcome (NCE) at 12 months after the procedure, and secondary endpoints will be followed up to 36 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
  • In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus.
  • Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator.
  • Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA).
  • Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
  • Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.

Exclusion criteria

  • Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
  • Patients with a life expectancy of less than 2 years due to comorbid conditions.
  • Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
  • Women who are pregnant or have childbearing potential.
  • Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
  • Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
  • Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.

Treatment and study plan

GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)

Device

GENOSS DCB is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native coronary arteries. GENOSS DCB has been demonstrated to reduce restenosis for the treatment of in-stent restenosis and de-novo lesions in coronary arteries narrowed by atherosclerosis. GENOSS DCB is designed to improve the lumen diameter and to reduce restenosis in the treatment of lesions in native coronary arteries. GENOSS DCB has been demonstrated to reduce restenosis for the treatment of in-stent restenosis and de-novo lesions in coronary arteries narrowed by atherosclerosis.

GENOSS DCB's active drug coating is located on the surface of the balloon, which contains 3ug Paclitaxel per 1mm2. The drug is embedded in a physiologically harmless and degradable delivery matrix (main component: shellac and vitamin E-TPGS).

Second, Third Generation Drug-Eluting Coronary Stent System

Device

Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.

Primary outcomes

  1. Net Clinical outcome (NCO)

    Time frame: at 12 months after procedure

    The primary endpoint is the net clinical outcome, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization (TVR), and BARC (Bleeding Academic Research Consortium) type 2 to 5 bleeding.

Secondary outcomes

  1. Net Clinical outcome (NCO)

    Time frame: at 24, and 36 months after procedure

    Net Clinical Outcome (NCO) is defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization (TVR), and BARC (Bleeding Academic Research Consortium) type 2 to 5 bleeding.

  2. Major adverse cardiovascular events (MACEs)

    Time frame: at 24, and 36 months after procedure

    Major adverse cardiovascular events (MACEs) are defined as a composite of cardiac death, non-fatal myocardial infarction, definite stent thrombosis, and stroke.

  3. Major adverse cardiac events (MACE)

    Time frame: at 24, and 36 months after procedure

    Major adverse cardiac events (MACE) is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and target vessel revascularization (TVR).

  4. Major bleeding

    Time frame: at 24, and 36 months after procedure

    Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding.

  5. All-cause death

    Time frame: at 24, and 36 months after procedure

  6. Cardiac death

    Time frame: at 24, and 36 months after procedure

    Cardiac death is defined according to the Academic Research Consortium (ARC) criteria and includes the following:

    • Death related to myocardial infarction (MI)
    • Sudden cardiac death (SCD)
    • Death due to heart failure
    • Death due to fatal arrhythmia
    • Other deaths without a clearly documented non-cardiac cause (Deaths of unknown cause are classified as cardiac deaths)

  7. Myocardial infarction

    Time frame: at 24, and 36 months after procedure

    ST elevation myocardial infarction and Non-ST elevation myocardial infarction will be evaluated.

    • Spontaneous MI (Type 1 MI)

    : Defined as a rise and/or fall of cardiac troponin with at least one value exceeding the 99th percentile upper reference limit, accompanied by clinical evidence of myocardial ischemia.

    • Periprocedural MI (Type 4a MI) : Defined as an elevation of cardiac troponin to ≥5 times the 99th percentile upper reference limit following PCI, accompanied by clinical evidence of ischemia (chest pain, ECG changes, imaging abnormalities, etc.).

    ST-segment elevation status (STEMI vs. NSTEMI) will be recorded as supplementary information but is not included in the primary endpoint definition.

  8. Target vessel-myocardial infaction (TV-MI)

    Time frame: at 24, and 36 months after procedure

  9. Target lesion revascularization (TLR)

    Time frame: at 24, and 36 months after procedure

  10. Target vessel revascularization (TVR)

    Time frame: at 24, and 36 months after procedure

  11. Definite or probable stent thrombosis

    Time frame: at 24, and 36 months after procedure

  12. Ischemic or hemorrhagic stroke

    Time frame: at 24, and 36 months after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Eun-Seok Shin, Cardiology

CONTACT

[email protected]

010-6319-4025

Sponsors and collaborators

Lead sponsor

Genoss Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: DCBMultivessel

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Apr 20, 2026
Registry last updated
Apr 20, 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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