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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Coronary Intervention; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Device: GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter); Device: Second, Third Generation Drug-Eluting Coronary Stent System

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

• Study Type: Interventional
• Enrollment (Estimated): 892
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eun-Seok Shin, Cardiology; Phone Number: 010-6319-4025; Email: sesim1989@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. 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.
3. 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.
4. 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).
5. Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
6. Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

1. Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
2. Patients with a life expectancy of less than 2 years due to comorbid conditions.
3. Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
4. Women who are pregnant or have childbearing potential.
5. 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.
6. Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GENOSS® DCB; Paclitaxel-coated PTCA Balloon Catheter	Device: 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).
Active Comparator: Second, Third Generation Drug-Eluting Coronary Stent System; All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES)	Device: Second, Third Generation Drug-Eluting Coronary Stent System; Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Clinical outcome (NCO)	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.	at 12 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	at 24, and 36 months after procedure
Major bleeding	Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding.	at 24, and 36 months after procedure
All-cause death		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)	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.	at 24, and 36 months after procedure
Target vessel-myocardial infaction (TV-MI)		at 24, and 36 months after procedure
Target lesion revascularization (TLR)		at 24, and 36 months after procedure
Target vessel revascularization (TVR)		at 24, and 36 months after procedure
Definite or probable stent thrombosis		at 24, and 36 months after procedure
Ischemic or hemorrhagic stroke		at 24, and 36 months after procedure

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): July 31, 2032

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CIP-DS1001-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No