RESOLUTE ONYX Post-Approval Study
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Registration Number
- NCT03063749
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Extra Large Vessel (XLV) Cohort. 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. Primary Cohort Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Acute Success (Device, Lesion, Procedure) 30 days and 6, 12, 24, and 36 months post-procedure Acute Success (Device, Lesion, Procedure)
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)
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 Vessel Revascularization (TVR) 30 days and 6, 12, 24, and 36 months post-procedure Target Vessel Revascularization (TVR)
Target Lesion Failure (TLF) 30 days and 6, 12, 24, and 36 months post-procedure Target Lesion Failure (TLF)
Cardiac Death 30 days and 6, 12, 24, and 36 months post-procedure Cardiac Death
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)
Trial Locations
- Locations (28)
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Mercy Hospital (Coon Rapids MN)
🇺🇸Coon Rapids, Minnesota, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Desert Springs Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Michigan Health System - University Hospital
🇺🇸Ann Arbor, Michigan, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Riverside Community Hospital
🇺🇸Riverside, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
🇺🇸New York, New York, United States
Saint Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
Saint Vincent Hospital (Green Bay WI)
🇺🇸Green Bay, Wisconsin, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
C.H.U. de Charleroi
🇧🇪Charleroi, Belgium
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
🇸🇰Banska Bystrica, Slovakia
Baptist Memorial Hospital-Memphis
🇺🇸Memphis, Tennessee, United States
Ziekenhuis Oost Limburg - Campus Sint-Jan
🇧🇪Genk, Belgium
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
Nebraska Medicine
🇺🇸Omaha, Nebraska, United States
TriStar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
🇫🇷Besancon, France