An observational study in Coronary Artery Disease, sponsored by Medtronic Vascular. Completed at 28 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Medtronic Vascular · Observational
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 416 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Medtronic Vascular is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.
Key Inclusion Criteria
Key Exclusion Criteria
Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort.
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
Target Lesion Failure
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
Time frame: 12 months
Acute Success (Device, Lesion, Procedure)
Acute Success (Device, Lesion, Procedure)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
Cardiac Death
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
Target Vessel Myocardial Infarction (TVMI)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
Target Lesion Revascularization (TLR)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI
Cardiac Death and TVMI
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Major Adverse Cardiac Event (MACE)
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
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Failure (TLF)
Target Lesion Failure (TLF)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)
Target Vessel Failure (TVF)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)
Stent Thrombosis (ST)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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