Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Brief 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.
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.
Interventions
DEVICEGENOSS® 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).
DEVICESecond, 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.
Sponsors
Genoss Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Clinical outcome (NCO) | at 12 months after procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net Clinical outcome (NCO) | at 24, and 36 months after procedure | 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. |
| Major adverse cardiovascular events (MACEs) | at 24, and 36 months after procedure | Major adverse cardiovascular events (MACEs) are defined as a composite of cardiac death, non-fatal myocardial infarction, definite stent thrombosis, and stroke. |
| Major adverse cardiac events (MACE) | at 24, and 36 months after procedure | Major adverse cardiac events (MACE) is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and target vessel revascularization (TVR). |
| Major bleeding | at 24, and 36 months after procedure | Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding. |
| All-cause death | at 24, and 36 months after procedure | — |
| Cardiac death | at 24, and 36 months after procedure | 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) |
| Myocardial infarction | at 24, and 36 months after procedure | ST elevation myocardial infarction and Non-ST elevation myocardial infarction will be evaluated. 1. 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. 2. 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. |
| 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 | — |
Contacts
CONTACTEun-Seok Shin, Cardiology
Outcome results
None listed