Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT07539324
Recruiting Not applicable

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

NCT07539324 · tracked via the Priya Life Science South Korea tracker
Sponsor
Genoss Co., Ltd
Phase
Not applicable
Started
2026-09-28
Last updated
2026-10-09

Condition(s) studied

Multi Vessel Coronary Artery DiseasePercutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)Contemporary Drug-Eluting Stents (DES)

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).

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.

Study 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 prospective, multicenter, active-controlled, randomized, investigator-initiated clinical trial.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this clinical study. 1. Adults aged ≥20 years with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI). 2. 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. 3. 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. 4. Patients with a reference vessel diameter (RVD) of ≥2.25 mm and ≤4.0 mm, as assessed by coronary angiography. 5. Patients in whom the investigator determines, based on coronary angiographic findings and clinical assessment, that PCI of the target lesion(s) is technically feasible. 6. Patients who voluntarily provide written informed consent to participate in the clinical trial and are willing and able to comply with the study requirements. Exclusion Criteria: Patients meeting any of the following criteria will be excluded from enrollment. 1. Cardiogenic shock or the need for mechanical or pharmacological circulatory support. 2. Life expectancy of ≤2 years due to concomitant medical conditions. 3. Current participation in, or planned participation in, another interventional clinical trial, excluding observational studies. 4. Pregnant women or women of childbearing potential. 5. 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. 6. A target lesion located within a saphenous vein graft or an arterial graft. 7. 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.

Primary outcome measure(s)

  • Net Clinical outcome (NCO) — 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.

Trial sites (1)

FacilityCityRegionStatus
Ulsan University Hospital Ulsan South Korea Recruiting

More Genoss Co., Ltd. trials in South Korea

Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion Recruiting
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion Enrolling by invitation
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease Enrolling by invitation
Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS) Active, not recruiting
Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES) Enrolling by invitation

Other trials for the same condition

Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator Recruiting
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease Recruiting
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI) Recruiting
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy Recruiting
Comparison of Safety and Efficacy Between the Robot-assisted System AVIAR (MX-02) Procedure and Conventional Manual Procedure in Patients Requiring Percutaneous Coronary Intervention Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07539324 on ClinicalTrials.gov ↗ ← All trials in South Korea