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Medtronic Resolute Onyx 2.0 mm Clinical Study

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ClinicalTrials.gov Identifier: NCT02412501
Recruitment Status : Active, not recruiting
First Posted : April 9, 2015
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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 that allows the use of a 2.0 mm diameter stent.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Resolute Onyx Stent - 2.0 mm Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study
Study Start Date : April 6, 2015
Actual Primary Completion Date : February 13, 2017
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Device
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent
Device: Resolute Onyx Stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent



Primary Outcome Measures :
  1. Number of Participants With Target Lesion Failure at 12 Months Post-Procedure [ Time Frame: 12 Months ]
    Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.


Secondary Outcome Measures :
  1. Number of Participants With Cardiac Death at 12 Months Post Procedure [ Time Frame: 12 Months ]
  2. Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure [ Time Frame: 12 Months ]
    TVMI defined as Q Wave or non-Q Wave MI

  3. Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure [ Time Frame: 12Months ]
  4. Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure [ Time Frame: 24 Months ]
  5. Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure [ Time Frame: 12 Months ]
  6. Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery
  • Must have evidence of ischemic heart disease
  • Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
  • 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

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): NCT02412501


Locations
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, Missouri
Barnes Jewish University
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
The Mount Sinai Medical Center
New York, New York, United States, 10029
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, 58102
United States, Ohio
University Hospitals Elyria Medical Center
Elyria, Ohio, United States, 44035
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
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
East Texas Medical Center
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Matthew J. Price, MD, FACC, FSCAI Scripps Green Hospital
Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital
  Study Documents (Full-Text)

Documents provided by Medtronic Vascular:
Study Protocol  [PDF] March 26, 2015
Statistical Analysis Plan  [PDF] February 23, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02412501     History of Changes
Other Study ID Numbers: Version 5.0 - 26Mar2015
First Posted: April 9, 2015    Key Record Dates
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases