Coronary Artery Disease
Conditions
Brief summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
Interventions
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Sponsors
Medtronic Vascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction * Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki Key
Exclusion criteria
* Unprotected left main disease * Subjects with planned PCI of three vessel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure | 12 months | Target Lesion Failure (TLF), defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | 30 days and 6, 12, 24, and 36 months post-procedure | Cardiac Death |
| Target Vessel Myocardial Infarction (TVMI) | 30 days and 6, 12, 24, and 36 months post-procedure | Target Vessel Myocardial Infarction (TVMI) |
| Target Lesion Revascularization (TLR) | 30 days and 6, 12, 24, and 36 months post-procedure | Target Lesion Revascularization (TLR) |
| Target Vessel Revascularization (TVR) | 30 days and 6, 12, 24, and 36 months post-procedure | Target Vessel Revascularization (TVR) |
| Acute Success (Device, Lesion, Procedure) | 30 days and 6, 12, 24, and 36 months post-procedure | Acute Success (Device, Lesion, Procedure) |
| Major Adverse Cardiac Event (MACE) | 30 days and 6, 12, 24, and 36 months post-procedure | Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods |
| Target Lesion Failure (TLF) | 30 days and 6, 12, 24, and 36 months post-procedure | Target Lesion Failure (TLF) |
| Target Vessel Failure (TVF) | 30 days and 6, 12, 24, and 36 months post-procedure | Target Vessel Failure (TVF) |
| Stent Thrombosis (ST) | 30 days and 6, 12, 24, and 36 months post-procedure | Stent Thrombosis (ST) |
| Cardiac Death and TVMI | 30 days and 6, 12, 24, and 36 months post-procedure | Cardiac Death and TVMI |
Countries
Belgium, France, Slovakia, United States
Outcome results
None listed