This trial is active, not recruiting.

Condition coronary artery disease
Treatment resolute onyx stent - 2.25 mm - 4.0 mm
Sponsor Medtronic Vascular
Start date April 2015
End date July 2016
Trial size 75 participants
Trial identifier NCT02419521, Version 2.0 - 23Mar2015


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Core (2.25 mm - 4.0 mm)
resolute onyx stent - 2.25 mm - 4.0 mm

Primary Outcomes

In-stent Late Lumen Loss as measured by quantitative coronary angiography
time frame: 8 Months

Secondary Outcomes

Cardiac Death
time frame: 8 Months
Target Vessel Myocardial Infarction (TVMI)
time frame: 8 Months
Target Lesion Revascularization (TLR)
time frame: 8 Months
Major Adverse Cardiac Event (MACE)
time frame: 8 Months
Target Lesion Failure (TLF)
time frame: 8 Months
Target Vessel Failure (TVF)
time frame: 8 Months
Stent Thrombosis (ST)
time frame: 8 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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

Additional Information

Official title A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study
Principal investigator Matthew J. Price, MD, FACC, FSCAI
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.