Multi Vessel Coronary Artery DiseaseDCBMultivesselNCT07539324
Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
A study testing GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter) and Contemporary Drug-Eluting Stents (DES) in people with Multi Vessel Coronary Artery Disease and Percutaneous Coronary Intervention, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter) and Contemporary Drug-Eluting Stents (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 892 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients meeting any of the following criteria will be excluded from enrollment.
- Cardiogenic shock or the need for mechanical or pharmacological circulatory support.
- Life expectancy of ≤2 years due to concomitant medical conditions.
- Current participation in, or planned participation in, another interventional clinical trial, excluding observational studies.
- Pregnant women or women of childbearing potential.
- 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.
- A target lesion located within a saphenous vein graft or an arterial graft.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Eun-Seok Shin, MD, PhD, +82-52-250-8838, sesim1989@gmail.com
About this study
Official 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
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.
Read the detailed description
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 time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization, and the secondary endpoint is the Net Clinical Outcome (NCO) through 36 months after the index procedure.
Successful lesion preparation for DCB treatment will not be used as an eligibility criterion before randomization. Lesion preparation will be performed after randomization according to the assigned treatment strategy and the protocol-specified procedural requirements.
- Being tested
- GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter), Contemporary Drug-Eluting Stents (DES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Contemporary Drug-Eluting Stents (DES)Device
Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.
| Study group | Role | What they receive |
|---|---|---|
| GENOSS® DCB | Experimental | Paclitaxel-coated PTCA Balloon Catheter Receives: Device: GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter) |
| Contemporary Drug-Eluting Stents (DES) | Active comparator | All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES) Receives: Device: Contemporary Drug-Eluting Stents (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Clinical outcome (NCO)
The primary endpoint is the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization.
NCO is defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target-vessel revascularization (CD-TVR), or BARC type 2-5 bleeding.
The time-to-event will be measured from the date of randomization to the date of the first occurrence of any component of the NCO.
Measured: the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization.
Secondary outcomes (12)
Net Clinical outcome (NCO)
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.
Measured: at 24, and 36 months after procedure
Major adverse cardiovascular events (MACEs)
Major adverse cardiovascular events (MACEs) are defined as a composite of cardiac death, non-fatal myocardial infarction, definite stent thrombosis, and stroke.
Measured: at 24, and 36 months after procedure
Major adverse cardiac events (MACE)
Major adverse cardiac events (MACE) is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and target vessel revascularization (TVR).
Measured: at 24, and 36 months after procedure
Major bleeding
Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding.
Measured: at 24, and 36 months after procedure
All-cause death
Measured: at 24, and 36 months after procedure
Cardiac death
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)
Measured: at 24, and 36 months after procedure
Myocardial infarction
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.
Measured: at 24, and 36 months after procedure
Target vessel-myocardial infaction (TV-MI)
Measured: at 24, and 36 months after procedure
Target lesion revascularization (TLR)
Measured: at 24, and 36 months after procedure
Target vessel revascularization (TVR)
Measured: at 24, and 36 months after procedure
Definite or probable stent thrombosis
Measured: at 24, and 36 months after procedure
Ischemic or hemorrhagic stroke
Measured: at 24, and 36 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start28 Sep 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Vessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 892 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539324
- Sponsor's protocol ID
- CIP-DS1001-4
- Acronym
- DCBMultivessel
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07539324
- Acronym / sponsor ID
- DCBMultivessel / CIP-DS1001-4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 892 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization, and the secondary endpoint is the Net Clinical Outcome (NCO) through 36 months after the index procedure.
Successful lesion preparation for DCB treatment will not be used as an eligibility criterion before randomization. Lesion preparation will be performed after randomization according to the assigned treatment strategy and the protocol-specified procedural requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GENOSS® DCB | Experimental | Device: GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)Paclitaxel-coated PTCA Balloon Catheter |
| Contemporary Drug-Eluting Stents (DES) | Active comparator | Device: Contemporary Drug-Eluting Stents (DES)All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients meeting any of the following criteria will be excluded from enrollment.
- Cardiogenic shock or the need for mechanical or pharmacological circulatory support.
- Life expectancy of ≤2 years due to concomitant medical conditions.
- Current participation in, or planned participation in, another interventional clinical trial, excluding observational studies.
- Pregnant women or women of childbearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)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). | Device | GENOSS® DCB |
| Contemporary Drug-Eluting Stents (DES)Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms. | Device | Contemporary Drug-Eluting Stents (DES) |
Primary outcome
Net Clinical outcome (NCO)
Time frame: the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization.
The primary endpoint is the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization. NCO is defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target-vessel revascularization (CD-TVR), or BARC type 2-5 bleeding. The time-to-event will be measured from the date of randomization to the date of the first occurrence of any component of the NCO.
12 secondary outcomes
Net Clinical outcome (NCO)
Time frame: at 24, and 36 months after procedure
Major adverse cardiovascular events (MACEs)
Time frame: at 24, and 36 months after procedure
Major adverse cardiac events (MACE)
Time frame: at 24, and 36 months after procedure
Major bleeding
Time frame: at 24, and 36 months after procedure
All-cause death
Time frame: at 24, and 36 months after procedure
Cardiac death
Time frame: at 24, and 36 months after procedure
Myocardial infarction
Time frame: at 24, and 36 months after procedure
Target vessel-myocardial infaction (TV-MI)
Time frame: at 24, and 36 months after procedure
Target lesion revascularization (TLR)
Time frame: at 24, and 36 months after procedure
Target vessel revascularization (TVR)
Time frame: at 24, and 36 months after procedure
Definite or probable stent thrombosis
Time frame: at 24, and 36 months after procedure
Ischemic or hemorrhagic stroke
Time frame: at 24, and 36 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter) and Contemporary Drug-Eluting Stents (DES) in people with Multi Vessel Coronary Artery Disease and Percutaneous Coronary Intervention, run by Genoss Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eun-Seok Shin, MD, PhD (+82-52-250-8838, sesim1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Clinical outcome (NCO) (time frame: the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.