Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
416 participants
OBSERVATIONAL
2017-03-30
2022-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Cohort
Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Extra Large Vessel (XLV) Cohort.
Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
Interventions
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Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Subjects with planned PCI of three vessel disease
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Locations
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Huntsville Hospital
Huntsville, Alabama, United States
Scripps Green Hospital
La Jolla, California, United States
Riverside Community Hospital
Riverside, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Mercy Hospital (Coon Rapids MN)
Coon Rapids, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Nebraska Medicine
Omaha, Nebraska, United States
Desert Springs Hospital Medical Center
Las Vegas, Nevada, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Saint Vincent Hospital (Green Bay WI)
Green Bay, Wisconsin, United States
C.H.U. de Charleroi
Charleroi, , Belgium
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, , Belgium
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, , France
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, , Slovakia
Countries
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Other Identifiers
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MDT16025RES003
Identifier Type: -
Identifier Source: org_study_id