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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Saint John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
  • New York
    • Roslyn, New York, United States, 11576
      • Saint Francis Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Medical Center
  • Ohio
    • Elyria, Ohio, United States, 44035
      • University Hospitals Elyria Medical Center
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Centennial Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Device; Medtronic Resolute Onyx Zotarolimus-Eluting Stent System	Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography	In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography	8 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Death		8 Months
Target Vessel Myocardial Infarction (TVMI)		8 Months
Target Lesion Revascularization (TLR)		8 Months
Major Adverse Cardiac Event (MACE)	Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods	8 Months
Target Lesion Failure (TLF)		8 Months
Target Vessel Failure (TVF)		8 Months
Stent Thrombosis (ST)		8 Months
Cardiac Death and TVMI		8 Months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Matthew J. Price, MD, FACC, FSCAI, Scripps Green Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2015
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Version 2.0 - 23Mar2015