RESOLUTE ONYX Post-Approval Study (ONYX PAS)

November 21, 2023 updated by: Medtronic Vascular

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 - Hopital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target Lesion Failure
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Success (Device, Lesion, Procedure)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Acute Success (Device, Lesion, Procedure)
30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI
30 days and 6, 12, 24, and 36 months post-procedure
Major Adverse Cardiac Event (MACE)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
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)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Failure (TLF)
30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)
30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)
Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)
30 days and 6, 12, 24, and 36 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Vascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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