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Completed

NCT Number: NCT03063749

RESOLUTE ONYX Post-Approval Study

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

C.H.U. de Charleroi, Charleroi, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

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

Acronym: ONYX PAS

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Feb 24, 2017
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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