Medtronic Resolute Onyx 2.0 mm Clinical Study



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:April 6, 2015
End Date:February 21, 2019

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A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study

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.


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
We found this trial at
17
sites
Clearwater, Florida 33756
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Clearwater, FL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Anderson, South Carolina 29621
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Anderson, SC
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Elyria, OH
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Fargo, North Dakota 58122
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Fargo, ND
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Indianapolis, Indiana 46260
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Indianapolis, IN
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La Jolla, California 92037
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La Jolla, CA
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Nashville, Tennessee 37203
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Nashville, TN
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New York, New York 10016
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New York, NY
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Roslyn, New York 11576
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Roslyn, NY
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Springfield, Illinois 62769
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Springfield, IL
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Tyler, Texas 75701
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Tyler, TX
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Wynnewood, Pennsylvania 19096
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Wynnewood, PA
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