Study Results
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View full resultsBasic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2015-04-06
2019-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent
Resolute Onyx Stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
Interventions
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Resolute Onyx Stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew J. Price, MD, FACC, FSCAI
Role: PRINCIPAL_INVESTIGATOR
Scripps Green Hospital
Shigeru Saito, MD
Role: PRINCIPAL_INVESTIGATOR
Shonan Kamakura General Hospital
Locations
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Scripps Green Hospital
La Jolla, California, United States
Morton Plant Hospital
Clearwater, Florida, United States
Saint John's Hospital
Springfield, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Barnes Jewish University
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
University Hospitals Elyria Medical Center
Elyria, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Dallas VA Medical Center
Dallas, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
Countries
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References
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Price MJ, Saito S, Shlofmitz RA, Spriggs DJ, Attubato M, McLaurin B, Popma Almonacid A, Brar S, Liu M, Moe E, Mehran R. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Version 5.0 - 26Mar2015
Identifier Type: -
Identifier Source: org_study_id
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