A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Medtronic Vascular12 sites in 1 country75 target enrollmentJuly 7, 2015

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Medtronic Vascular
Enrollment: 75
Locations: 12
Primary Endpoint: In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 7, 2015

End Date

December 3, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

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