RESOLUTE ONYX Post-Approval Study (ONYX PAS)

A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

• Study Type: Observational
• Enrollment (Actual): 416

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium, 6042
    • C.H.U. de Charleroi
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg - Campus Sint-Jan
• France
  • Besancon, France, 25030
    • Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
  • Toulouse, France, 50032 31059
    • CHU Toulouse - Hôpital Rangueil
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Stredoslovensky ustav srdcovych a cievnych chorob a.s
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801-4421
      • Huntsville Hospital
  • California
    • La Jolla, California, United States, 92037-1027
      • Scripps Green Hospital
    • Riverside, California, United States, 92501-4135
      • Riverside Community Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Marietta, Georgia, United States, 30060-1101
      • WellStar Kennestone Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan Health System - University Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital (Coon Rapids MN)
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Nebraska Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Desert Springs Hospital Medical Center
  • New York
    • Manhasset, New York, United States, 11030-3816
      • North Shore University Hospital
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NewYork Presbyterian Hospital
    • Syracuse, New York, United States, 13203-1898
      • Saint Joseph's Hospital Health Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital-Memphis
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center
  • Texas
    • Houston, Texas, United States, 77030-2703
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital (Green Bay WI)

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.

Description

Key Inclusion Criteria

• Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
• Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki

Key Exclusion Criteria

• Unprotected left main disease
• Subjects with planned PCI of three vessel disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Cohort; Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm; Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
Extra Large Vessel (XLV) Cohort.; Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort.	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm; Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure	Target Lesion Failure (TLF), defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Success (Device, Lesion, Procedure)	Acute Success (Device, Lesion, Procedure)	30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death	Cardiac Death	30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)	Target Vessel Myocardial Infarction (TVMI)	30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)	Target Lesion Revascularization (TLR)	30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR)	30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI	Cardiac Death and TVMI	30 days and 6, 12, 24, and 36 months post-procedure
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	30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Failure (TLF)	Target Lesion Failure (TLF)	30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)	Target Vessel Failure (TVF)	30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)	Stent Thrombosis (ST)	30 days and 6, 12, 24, and 36 months post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): October 20, 2018
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

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; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: MDT16025RES003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No