ONYX PAS: RESOLUTE ONYX Post-Approval Study
Study Details
Study Description
Brief Summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Cohort 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
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
| 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. |
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Acute Success (Device, Lesion, Procedure) [30 days and 6, 12, 24, and 36 months post-procedure]
Acute Success (Device, Lesion, Procedure)
- 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)
- Cardiac Death and TVMI [30 days and 6, 12, 24, and 36 months post-procedure]
Cardiac Death and TVMI
- 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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsville Hospital | Huntsville | Alabama | United States | 35801-4421 |
| 2 | Scripps Green Hospital | La Jolla | California | United States | 92037-1027 |
| 3 | Riverside Community Hospital | Riverside | California | United States | 92501-4135 |
| 4 | Hartford Hospital | Hartford | Connecticut | United States | 06106 |
| 5 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 6 | North Florida Regional Medical Center | Gainesville | Florida | United States | 32605 |
| 7 | Tallahassee Memorial Hospital | Tallahassee | Florida | United States | 32308 |
| 8 | WellStar Kennestone Hospital | Marietta | Georgia | United States | 30060-1101 |
| 9 | University of Michigan Health System - University Hospital | Ann Arbor | Michigan | United States | 48109-5000 |
| 10 | Mercy Hospital (Coon Rapids MN) | Coon Rapids | Minnesota | United States | 55433 |
| 11 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 12 | Nebraska Medicine | Omaha | Nebraska | United States | 68105 |
| 13 | Desert Springs Hospital Medical Center | Las Vegas | Nevada | United States | 89119 |
| 14 | North Shore University Hospital | Manhasset | New York | United States | 11030-3816 |
| 15 | NYU Langone Medical Center | New York | New York | United States | 10016 |
| 16 | Columbia University Medical Center/NewYork Presbyterian Hospital | New York | New York | United States | 10032 |
| 17 | Saint Joseph's Hospital Health Center | Syracuse | New York | United States | 13203-1898 |
| 18 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 19 | Baptist Memorial Hospital-Memphis | Memphis | Tennessee | United States | 38120 |
| 20 | TriStar Centennial Medical Center | Nashville | Tennessee | United States | 37203 |
| 21 | Houston Methodist Hospital | Houston | Texas | United States | 77030-2703 |
| 22 | University of Virginia Medical Center | Charlottesville | Virginia | United States | 22908 |
| 23 | Saint Vincent Hospital (Green Bay WI) | Green Bay | Wisconsin | United States | 54301 |
| 24 | C.H.U. de Charleroi | Charleroi | Belgium | 6042 | |
| 25 | Ziekenhuis Oost Limburg - Campus Sint-Jan | Genk | Belgium | 3600 | |
| 26 | Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz | Besancon | France | 25030 | |
| 27 | CHU Toulouse - Hôpital Rangueil | Toulouse | France | 50032 31059 | |
| 28 | Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banska Bystrica | Slovakia | 97401 |
Sponsors and Collaborators
- Medtronic Vascular
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT16025RES003