The objectives of this study are 1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent. 2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent. 3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.
Secondary endpoints are 1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention), 2. Target vessel failure 3. Composite rate of cardiac death and any MI, 3 years 4. Composite rate of all death and any MI 5. Composite rate of all death, any MI, and any repeat revascularization 6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy 7. Clinical device and procedural success
Study Type
OBSERVATIONAL
Enrollment
4,000
Kosin University Gospel Hospital
Busan, South Korea
RECRUITINGSoon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
RECRUITINGMyongji Hospital
Goyang, South Korea
RECRUITINGGwangju Christian Hospital
Gwangju, South Korea
RECRUITINGKwangju Veterans Hospital
Gwangju, South Korea
RECRUITINGChungbuk National University Hospital
Jeonju, South Korea
RECRUITINGPresbyterian Medical Center
Jeonju, South Korea
RECRUITINGGyeongsang National University Hospital
Jinju, South Korea
RECRUITINGPusan National University Hospital
Pusan, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
RECRUITING...and 6 more locations
Target lesion failure
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
Time frame: 12 months
Stent thrombosis, acute
according to Academic Research Consortium (ARC) definition
Time frame: within 24 hours after index PCI
Stent thrombosis, subacute
according to ARC definition
Time frame: from 24 hours to 30 days after index PCI
Stent thrombosis, late
according to ARC definition
Time frame: from 30 days to 1 year after index PCI
Stent thrombosis, very-late
according to ARC definition
Time frame: 1 year ~ up to 3 years
Target vessel failure
Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Time frame: 12 months
Composite rate of cardiac death and myocardial infarction
as title
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
as title
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
as title
Time frame: 12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
we will estimate this outcome with relevant questionnaire
Time frame: 12 months, 3 years
Clinical device and procedural success rate
device success : residual stenosis \<30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure
Time frame: intraoperative ( index PCI)
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