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RESOLUTE ONYX Post-Approval Study (ONYX PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063749
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Study Design
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Study Type : Observational
Actual Enrollment : 416 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : August 18, 2022
Groups and Cohorts
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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
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 4.5 mm - 5.0 mm


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Acute Success (Device, Lesion, Procedure) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Acute Success (Device, Lesion, Procedure)

  2. Cardiac Death [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Cardiac Death

  3. Target Vessel Myocardial Infarction (TVMI) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Target Vessel Myocardial Infarction (TVMI)

  4. Target Lesion Revascularization (TLR) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Target Lesion Revascularization (TLR)

  5. Target Vessel Revascularization (TVR) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Target Vessel Revascularization (TVR)

  6. Cardiac Death and TVMI [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Cardiac Death and TVMI

  7. 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

  8. Target Lesion Failure (TLF) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Target Lesion Failure (TLF)

  9. Target Vessel Failure (TVF) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Target Vessel Failure (TVF)

  10. Stent Thrombosis (ST) [ Time Frame: 30 days and 6, 12, 24, and 36 months post-procedure ]
    Stent Thrombosis (ST)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063749


Locations
Show Show 28 study locations
Sponsors and Collaborators
Medtronic Vascular
More Information
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03063749    
Other Study ID Numbers: MDT16025RES003
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs