None listed
Conditions
Interventions
Medical Device : Random DESyne™ stent and Orsiro™ stent (3:1)
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient over 20 years old 2) Those who have objective ischemia symptoms such as Stable MI, Unstable MI, Acute or Recent MI or have objective evidence suggesting ischemia by electrocardiogram or functional tests (However, if coronary artery stenosis is more than 70%, no mention of objective ischemia is required) 3) RVD 2.5-4.0mm, Lesion that could be treated with stents. 4) One or more epicardial coronary artery stenosis (above 50%) 5) Patient who agree to sign on ICF.
Exclusion criteria
Exclusion criteria: 1) Patient with cardiogenic shock or SBP less than 80 mmHg. 2) Persons with known hypersensitivity or contraindications to the following drugs and substances: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Biolimus A9, Novolimus, Stainless steal, Cobalt chromium, Contrast agent (However, even subjects with hypersensitivity to contrast agents could be registered if they could be controlled by steroids and pheniramine, but those with known anaphylaxis are excluded.) 3) Lactating and pregnant women. Women who wish to participate other clinical trials. 4) Patient who life expectancy is less than 1 year 5) Patients who disagree to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiogenic death, Q wave MI, or incidence of target lesion failure related to the occurrence of clinically indicated target lesion revascularization at 12 months after PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) All death 2) Cardiogenic death 3) MI: Q-MI, Non-Q-MI 4) clinical driven TLR 5) clinical driven TVR 6) Any revascularization 7) Stent thrombosis(ARC standard) | — |
Countries
Korea, Republic of
Contacts
Public ContactDo-Hee Kim
Koera University Guro Hospital
Outcome results
None listed