Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02419521

Run by

Medtronic Vascular

People needed

75

Starts

2015-07-07

Expected to finish

2018-12-03

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Scripps Green Hospital — La Jolla, California, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Saint John's Hospital — Springfield, Illinois, United States
• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
• Saint Francis Hospital — Roslyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Sanford Medical Center — Fargo, North Dakota, United States
• University Hospitals Elyria Medical Center — Elyria, Ohio, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• AnMed Health Medical Center — Anderson, South Carolina, United States
• Centennial Medical Center — Nashville, Tennessee, United States
• Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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