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

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02419521

Version 2.0 - 23Mar2015

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Device

Other group

Description:

Medtronic Resolute Onyx Zotarolimus-Eluting Stent System

Treatment:

Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm