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RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

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ClinicalTrials.gov Identifier: NCT03584464
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE May 14, 2018
Actual Primary Completion Date November 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
Official Title  ICMJE A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Study Arms  ICMJE Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Intervention: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2019)
205
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
200
Estimated Study Completion Date  ICMJE April 2023
Actual Primary Completion Date November 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584464
Other Study ID Numbers  ICMJE V 4.0 16Feb2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Vascular
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP