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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSS® DCB | Experimental | Paclitaxel-coated PTCA Balloon Catheter |
|
| Second, Third Generation Drug-Eluting Coronary Stent System | Active Comparator | All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 24, and 36 months after procedure |
| Major adverse cardiovascular events (MACEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun-Seok Shin, Cardiology | Contact | 010-6319-4025 | sesim1989@gmail.com |
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|
| Second, Third Generation Drug-Eluting Coronary Stent System | Device | Contemporary drug-eluting stents (DES) with either biodegradable or non-biodegradable (durable) polymer coatings, covering all regulatory-approved, thin-strut metal platforms. |
|
Major adverse cardiovascular events (MACEs) are defined as a composite of cardiac death, non-fatal myocardial infarction, definite stent thrombosis, and stroke. |
| at 24, and 36 months after procedure |
| 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). | at 24, and 36 months after procedure |
| Major bleeding | Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding. | at 24, and 36 months after procedure |
| All-cause death | at 24, and 36 months after procedure |
| Cardiac death | Cardiac death is defined according to the Academic Research Consortium (ARC) criteria and includes the following:
| at 24, and 36 months after procedure |
| Myocardial infarction | ST elevation myocardial infarction and Non-ST elevation myocardial infarction will be evaluated.
ST-segment elevation status (STEMI vs. NSTEMI) will be recorded as supplementary information but is not included in the primary endpoint definition. | at 24, and 36 months after procedure |
| 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 |