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

Sponsor: Genoss Co., Ltd. • ClinicalTrials.gov ID: NCT07539324

Registry updated: 2026-10-09

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Description

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.

Interventions

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.

Eligibility criteria

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.

Conditions

Multi Vessel Coronary Artery Disease Percutaneous Coronary Intervention

Locations

Ulsan University Hospital — Ulsan, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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