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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-07

Study Completion Date

2018-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device

Medtronic Resolute Onyx Zotarolimus-Eluting Stent System

Group Type OTHER

Resolute Onyx Stent - 2.25 mm - 4.0 mm

Intervention Type DEVICE

Interventions

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Resolute Onyx Stent - 2.25 mm - 4.0 mm

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No