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Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

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: NCT02419521
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : July 28, 2017
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Actual Study Start Date : July 7, 2015
Actual Primary Completion Date : July 5, 2016
Actual Study Completion Date : December 3, 2018
Arms and Interventions
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Arm Intervention/treatment
Device
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
 Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm


Outcome Measures
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Primary Outcome Measures :
  1. In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography [ Time Frame: 8 Months ]
    In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography


Secondary Outcome Measures :
  1. Cardiac Death [ Time Frame: 8 Months ]
  2. Target Vessel Myocardial Infarction (TVMI) [ Time Frame: 8 Months ]
  3. Target Lesion Revascularization (TLR) [ Time Frame: 8 Months ]
  4. Major Adverse Cardiac Event (MACE) [ Time Frame: 8 Months ]
    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

  5. Target Lesion Failure (TLF) [ Time Frame: 8 Months ]
  6. Target Vessel Failure (TVF) [ Time Frame: 8 Months ]
  7. Stent Thrombosis (ST) [ Time Frame: 8 Months ]
  8. Cardiac Death and TVMI [ Time Frame: 8 Months ]

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
Criteria

Inclusion Criteria:

  • Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
  • Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
  • Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
  • Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

  • Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
  • Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
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): NCT02419521


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
United States, Illinois
Saint John's Hospital
Springfield, Illinois, United States, 62701
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, New York
Saint Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, North Dakota
Sanford Medical Center
Fargo, North Dakota, United States, 58122
United States, Ohio
University Hospitals Elyria Medical Center
Elyria, Ohio, United States, 44035
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
United States, Tennessee
Centennial Medical Center
Nashville, Tennessee, United States, 37205
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: Matthew J. Price, MD, FACC, FSCAI Scripps Green Hospital
More Information
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02419521    
Other Study ID Numbers: Version 2.0 - 23Mar2015
First Posted: April 17, 2015    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: April 3, 2019
Last Verified: March 2019
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