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Completed

NCT Number: NCT03584464

RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

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

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

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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

Interventional

Phase

Not applicable

Primary location

CHU 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
  • Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique

Exclusion criteria

  • Unprotected left main disease
  • Subjects with planned PCI of three vessel disease
  • Planned two stent technique (main branch and side branch) of a bifurcation
  • Subjects with more than one bifurcation lesion

Treatment and study plan

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Primary outcomes

  1. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 12 Months

    Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Secondary outcomes

  1. Number of Participants With Cardiac Death

    Time frame: 12 months

    Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.

  2. Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)

    Time frame: Up to 12 months

    Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)

  3. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 12 months

    Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.

  4. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 12 months

    Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.

  5. Number of Participants With Cardiac Death and TVMI

    Time frame: 12 months

    Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.

  6. Number of Participants With Major Adverse Cardiac Event (MACE)

    Time frame: 12 months

    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.

  7. Number of Participants With Target Lesion Failure (TLF)

    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.

  8. Number of Participants With Stent Thrombosis (ARC) Definite/Probable

    Time frame: 12 months

    Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC).

    Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.

    Probable: Any unexplained death within the first 30 days.

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jul 12, 2018
Registry last updated
Nov 24, 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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