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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Korea University Anam Hospital
Seoul, Seoul, South Korea
Target Lesion Failure (TLF)
The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)
Time frame: at 12 months after the procedure
All deaths
Time frame: at 12 months after the procedure
Cardiac death
Time frame: at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)
Time frame: at 12 months after the procedure
any MI (myocardial infarction)
Time frame: at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)
Time frame: at 12 months after the procedure
ID-TLR (ischemia-driven target lesion revascularization)
Time frame: at 12 months after the procedure
Stent thrombosis by ARC definition
Time frame: at 12 months after the procedure
Procedure success
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.
Time frame: during the hospitalization period (up to 3 days)
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