Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm
- Registration Number
- NCT02419521
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
- Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Concurrent medical condition with a life expectancy of less than 12 months
- Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
- Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device Resolute Onyx Stent - 2.25 mm - 4.0 mm Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
- Primary Outcome Measures
Name Time Method In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography 8 Months In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
- Secondary Outcome Measures
Name Time Method Cardiac Death 8 Months Target Vessel Failure (TVF) 8 Months Target Lesion Revascularization (TLR) 8 Months Target Vessel Myocardial Infarction (TVMI) 8 Months Stent Thrombosis (ST) 8 Months Cardiac Death and TVMI 8 Months Major Adverse Cardiac Event (MACE) 8 Months 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) 8 Months
Trial Locations
- Locations (12)
Sanford Medical Center
🇺🇸Fargo, North Dakota, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Saint John's Hospital
🇺🇸Springfield, Illinois, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
University Hospitals Elyria Medical Center
🇺🇸Elyria, Ohio, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States