Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris
Conditions
Keywords
coronary artery disease, percutaneous coronary intervention, zotarolimus-eluting stents
Brief summary
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.
Detailed description
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
Interventions
DEVICEResolute Onyx
Sponsors
Medtronic
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 19 * Patients who received PCI with Resolute Onyx™ stent(s)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 12 months | Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis, late | from 30 days to 1 year after index PCI | according to ARC definition |
| Stent thrombosis, acute | within 24 hours after index PCI | according to Academic Research Consortium (ARC) definition |
| Stent thrombosis, very-late | 1 year ~ up to 3 years | according to ARC definition |
| Target vessel failure | 12 months | Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR) |
| Stent thrombosis, subacute | from 24 hours to 30 days after index PCI | according to ARC definition |
| Composite rate of all-cause death and any myocardial infarction | 12 months, 3 years | as title |
| Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization | 12 months, 3 years | as title |
| Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy | 12 months, 3 years | we will estimate this outcome with relevant questionnaire |
| Clinical device and procedural success rate | intraoperative ( index PCI) | 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 |
| Composite rate of cardiac death and myocardial infarction | 12 months, 3 years | as title |
Countries
South Korea
Contacts
Primary ContactHyo-soo Kim, MD, PhD
Outcome results
None listed