Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
205 participants
INTERVENTIONAL
2018-05-14
2022-09-28
Brief Summary
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To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 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 - 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
* Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Exclusion Criteria
* Subjects with planned PCI of three vessel disease
* Planned two stent technique (main branch and side branch) of a bifurcation
* Subjects with more than one bifurcation lesion
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
Ann Arbor, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Desert Springs Hospital
Las Vegas, Nevada, United States
St. Josephs Hospital Health Center
East Syracuse, New York, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
New York-Presbyterian Hospital/ Columbia University Medical Center
New York, New York, United States
Baptist Memorial Hospital-Memphis
Germantown, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
CHU Charleroi
Charleroi, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, , Slovakia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Ver 4.0 16Feb2018
Identifier Type: -
Identifier Source: org_study_id