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RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

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ClinicalTrials.gov Identifier: NCT03584464
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm




Primary Outcome Measures :
  1. Number of participants with Target Vessel Failure (TVF) at 12 months post procedure [ Time Frame: 12 Months ]
    Target Lesion Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.


Secondary Outcome Measures :
  1. Number of participants with Acute Success (Device, Lesion, Procedure) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Acute Success (Device, Lesion, Procedure) defined as attainment of < 50% residual stenosis of the target vessel.

  2. Number of participants with Cardiac Death at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.

  3. Number of participants with Target Vessel Myocardial Infarction (TVMI) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel.

  4. Number of participants with Target Lesion Revascularization (TLR) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Target Lesion Revascularization (TLR) defined as repeat PCI, CABG to the target lesion, or clinically driven target lesion revascularization.

  5. Number of participants with Target Vessel Revascularization (TVR) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.

  6. Number of participants with Cardiac Death and TVMI at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.

  7. Number of participants with Major Adverse Cardiac Event (MACE) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 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.

  8. Number of participants with Target Lesion Failure (TLF) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 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.

  9. Number of participants with Target Vessel Failure (TVF) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

  10. Number of participants with Stent Thrombosis (ST) at hospital discharge, 30 days and 6, 12, 24, and 36 months post-procedure [ Time Frame: Up to 36 months ]
    Stent Thrombosis (ST) defined per Academic Research Consortium (ARC).



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

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): NCT03584464


Contacts
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Contact: Alissa Anderson (763) 514-4000 rs.onyxpas@medtronic.com

Locations
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United States, California
Scripps Green Hospital Not yet recruiting
La Jolla, California, United States, 92037
Contact: Matthew Price, MD    858-554-5032    price.matthew@scrippshealth.org   
Principal Investigator: Matthew Price, MD         
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Douglas Spriggs, MD    727-510-3966    rschdjs@cccheart.com   
Principal Investigator: Douglas Spriggs, MD         
United States, Minnesota
Abbott Northwestern Hospital Not yet recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Yale Wang, MD    612-863-3900    yale.wang@allina.com   
Principal Investigator: Yale Wang, MD         
United States, New York
NYU Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Michael Attubato, MD    212-263-5656    michael.attubato@nyumc.org   
Principal Investigator: Michael Attubato, MD         
United States, Tennessee
Centennial Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37205
Contact: Paul Myers, MD    615-515-2100    Paul.Myers@hcahealthcare.com   
Principal Investigator: Paul Myers, MD         
Sponsors and Collaborators
Medtronic Vascular

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03584464     History of Changes
Other Study ID Numbers: V 4.0 16Feb2018
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
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