Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorGenoss Co., Ltd.
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)
DeviceGENOSS 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)
DeviceContemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms.
Treatment groups
892 Participants
are divided into 2 treatment groupsGroup A: GENOSS® DCBExperimental treatment 1 intervention
Group B: Contemporary Drug-Eluting Stents (DES)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
the time to the first occurrence of a Net Clinical Outcome (NCO) within 12 months after randomization.Secondary outcomes
1
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.
Time frame
at 24, and 36 months after procedure2
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.
Time frame
at 24, and 36 months after procedure3
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).
Time frame
at 24, and 36 months after procedure4
Major bleeding
Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding.
Time frame
at 24, and 36 months after procedureSponsors and contacts
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Source ClinicalTrials.gov