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To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort | Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort. |
| |
| Extra Large Vessel (XLV) Cohort. | Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device | Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success (Device, Lesion, Procedure) | Acute Success (Device, Lesion, Procedure) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Cardiac Death | Cardiac Death |
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Key Inclusion Criteria
Key Exclusion Criteria
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The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Huntsville | Alabama | 35801-4421 | United States | ||
| Scripps Green Hospital |
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| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device | Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm |
|
| 30 days and 6, 12, 24, and 36 months post-procedure |
| Target Vessel Myocardial Infarction (TVMI) | Target Vessel Myocardial Infarction (TVMI) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Target Lesion Revascularization (TLR) | Target Lesion Revascularization (TLR) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Cardiac Death and TVMI | Cardiac Death and TVMI | 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 | 30 days and 6, 12, 24, and 36 months post-procedure |
| Target Lesion Failure (TLF) | Target Lesion Failure (TLF) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) | 30 days and 6, 12, 24, and 36 months post-procedure |
| Stent Thrombosis (ST) | Stent Thrombosis (ST) | 30 days and 6, 12, 24, and 36 months post-procedure |
| La Jolla |
| California |
| 92037-1027 |
| United States |
| Riverside Community Hospital | Riverside | California | 92501-4135 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| WellStar Kennestone Hospital | Marietta | Georgia | 30060-1101 | United States |
| University of Michigan Health System - University Hospital | Ann Arbor | Michigan | 48109-5000 | United States |
| Mercy Hospital (Coon Rapids MN) | Coon Rapids | Minnesota | 55433 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Nebraska Medicine | Omaha | Nebraska | 68105 | United States |
| Desert Springs Hospital Medical Center | Las Vegas | Nevada | 89119 | United States |
| North Shore University Hospital | Manhasset | New York | 11030-3816 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center/NewYork Presbyterian Hospital | New York | New York | 10032 | United States |
| Saint Joseph's Hospital Health Center | Syracuse | New York | 13203-1898 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Baptist Memorial Hospital-Memphis | Memphis | Tennessee | 38120 | United States |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030-2703 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Saint Vincent Hospital (Green Bay WI) | Green Bay | Wisconsin | 54301 | United States |
| C.H.U. de Charleroi | Charleroi | 6042 | Belgium |
| Ziekenhuis Oost Limburg - Campus Sint-Jan | Genk | 3600 | Belgium |
| Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| CHU Toulouse - Hôpital Rangueil | Toulouse | 50032 31059 | France |
| Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banská Bystrica | 97401 | Slovakia |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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