Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Brief summary
The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.
Detailed description
This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events. This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions. As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.
Interventions
The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
Sponsors
Genoss Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
\<Inclusion Criteria\> * Adults over 19 years of age * Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions) * Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES * Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form. (However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.) \<
Exclusion criteria
\> * Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded) * When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded. * Those whose remaining life expectancy is less than 1 year * Expecting to become pregnant, pregnant or lactating woman * The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment. Subject * If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study. * Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | at 12 months after the procedure | The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | at 12 months after the procedure | — |
| Non-cardiac death | at 12 months after the procedure | — |
| TV-MI (target vessel-myocardial infarction) | at 12 months after the procedure | — |
| Non-target vessel myocardial infarction | at 12 months after the procedure | — |
| Major adverse cardiac events (MACE) | at 12 months after the procedure | The composite end point of death, myocardial infarction, target lesion revascularization |
| Non-ischemia driven target vessel revascularization | at 12 months after the procedure | — |
| Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year | within 24 hours, 30 days, 1 year | Acute (within 24 hours), subacute (within 30 days), late (within 1 year) |
| Device success | during the procedure | The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact. |
| Procedure success | during the hospitalization period (up to 3 days) | When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period. |
| ID-TVR (ischemia-driven target vessel revascularization) | at 12 months after the procedure | — |
Countries
South Korea
Outcome results
None listed