Coronary Artery Disease, Drug-eluting Stent
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGenoss DES
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.
Sponsors
Severance Hospital
Genoss Co., Ltd.
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 19 years * Subject has signed informed consent for data release
Exclusion criteria
* Subject did not sign informed consent for data release * Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media * Pregnancy * Subject with life expectancy less than 12 months * Subject with cardiogenic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with device-oriented compopsite endpoint (TLF) | 12 months | A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with target-vessel myocardial infarction (TV-MI) | 12 months | A composite rate of target-vessel myocardial infarction (TV-MI) |
| Number of participants with all revascularization | 12 months | A composite rate of all revascularization |
| Number of participants with patient-oriented composite endpoint | 12 months | A composite rate of all death, all myocardial infarction, and all revascularization |
| Number of participants with all death | 12 months | A composite rate of all death |
| Number of participants with cardiac death | 12 months | A composite rate of cardiac death |
| Number of participants with all myocardial infarction | 12 months | A composite rate of all myocardial infarction |
| Number of participants with ischemic driven target lesion revascularization (ID-TLR) | 12 months | A composite rate of ischemic driven target lesion revascularization (ID-TLR) |
| Number of participants with stent thrombosis | Within 24 hours, 30 days, 12 months | A composite rate of stent thrombosis |
| Number of participants with non-ischemic targeted lesion perfusion | 12 months | A composite rate of non-ischemic targeted lesion perfusion |
| Number of participants with Non target vessel myocardial infarction | 12 months | A composite rate of Non target vessel myocardial infarction |
| Number of participants with non-cardiac death | 12 months | A composite rate of non-cardiac death |
Countries
South Korea
Outcome results
None listed