This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.
It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.
Study Type
OBSERVATIONAL
Enrollment
200
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Number of participants with device-oriented compopsite endpoint (TLF)
A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)
Time frame: 12 months
Number of participants with patient-oriented composite endpoint
A composite rate of all death, all myocardial infarction, and all revascularization
Time frame: 12 months
Number of participants with all death
A composite rate of all death
Time frame: 12 months
Number of participants with cardiac death
A composite rate of cardiac death
Time frame: 12 months
Number of participants with non-cardiac death
A composite rate of non-cardiac death
Time frame: 12 months
Number of participants with all myocardial infarction
A composite rate of all myocardial infarction
Time frame: 12 months
Number of participants with target-vessel myocardial infarction (TV-MI)
A composite rate of target-vessel myocardial infarction (TV-MI)
Time frame: 12 months
Number of participants with all revascularization
A composite rate of all revascularization
Time frame: 12 months
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Number of participants with ischemic driven target lesion revascularization (ID-TLR)
A composite rate of ischemic driven target lesion revascularization (ID-TLR)
Time frame: 12 months
Number of participants with stent thrombosis
A composite rate of stent thrombosis
Time frame: Within 24 hours, 30 days, 12 months
Number of participants with non-ischemic targeted lesion perfusion
A composite rate of non-ischemic targeted lesion perfusion
Time frame: 12 months
Number of participants with Non target vessel myocardial infarction
A composite rate of Non target vessel myocardial infarction
Time frame: 12 months