Medtronic Resolute Onyx 2.0 mm Clinical Study

A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 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 that allows the use of a 2.0 mm diameter stent.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Resolute Onyx Stent - 2.0 mm

• Study Type: Interventional
• Enrollment (Actual): 101
• 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
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish University
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
    • 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, 58102
      • Sanford Medical Center
  • Ohio
    • Elyria, Ohio, United States, 44035
      • University Hospitals Elyria Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • 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
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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, stenting, & emergent coronary artery bypass graft (CABG) surgery
• Must have evidence of ischemic heart disease
• Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
• 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 Coronary Stent System 2.0 mm Stent	Device: Resolute Onyx Stent - 2.0 mm; Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure	Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cardiac Death at 12 Months Post Procedure		12 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	12 Months
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure		12Months
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure		24 Months
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure		12 Months
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure		12 Months
Number of Participants With Cardiac Death at 24 Months Post Procedure		24 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	24 Months
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure		24 Months
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure		24 Months
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure		24 Months
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure		36 Months
Number of Participants With Cardiac Death at 36 Months Post Procedure		36 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	36 Months
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure		36 Months
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure		36 Months
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure		36 Months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Price MJ, Saito S, Shlofmitz RA, Spriggs DJ, Attubato M, McLaurin B, Popma Almonacid A, Brar S, Liu M, Moe E, Mehran R. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2015
• Primary Completion (Actual): February 13, 2017
• Study Completion (Actual): February 21, 2019

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 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 5.0 - 26Mar2015