Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
Trial statusNot yet recruiting
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
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).
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.
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.
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).
Disqualifiers
Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
Patients with a life expectancy of less than 2 years due to comorbid conditions.
Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
Women who are pregnant or have 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).
Second, Third Generation Drug-Eluting Coronary Stent System
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: Second, Third Generation Drug-Eluting Coronary Stent SystemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at 12 months after procedureSecondary 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 procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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