Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Brief summary
In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.
Detailed description
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent. As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions 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
Healthy volunteers
No
Inclusion criteria
\<Inclusion Criteria\> 1. Adults over 19 years of age 2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty. 3. Severe coronary artery stenosis suitable for GENOSS® DES insertion 4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution. \<
Exclusion criteria
\> 1. 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) 2. Patients who also received other drug-eluting stents 3. If you have a disease with a remaining life expectancy of less than 1 year 4. Pregnant or lactating women or women who may be pregnant 5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low. 6. Patients judged by researchers to be unsuitable for research
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 | — |
| TV-MI (target vessel-myocardial infarction) | at 12 months after the procedure | — |
| any MI (myocardial infarction) | at 12 months after the procedure | — |
| All deaths | at 12 months after the procedure | — |
| ID-TLR (ischemia-driven target lesion revascularization) | at 12 months after the procedure | — |
| Stent thrombosis by ARC definition | at 12 months after the procedure | — |
| Procedure success | during the hospitalization period (up to 3 days) | When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization. |
| ID-TVR (ischemia-driven target vessel revascularization) | at 12 months after the procedure | — |
Countries
South Korea
Outcome results
None listed