A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Status: Completed
Location: See all (28) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction

• 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

Locations
United States
Alabama
Huntsville Hospital
Huntsville
California
Scripps Green Hospital
La Jolla
Riverside Community Hospital
Riverside
Connecticut
Hartford Hospital
Hartford
Florida
Morton Plant Hospital
Clearwater
North Florida Regional Medical Center
Gainesville
Tallahassee Memorial Hospital
Tallahassee
Georgia
WellStar Kennestone Hospital
Marietta
Michigan
University of Michigan Health System - University Hospital
Ann Arbor
Minnesota
Mercy Hospital (Coon Rapids MN)
Coon Rapids
Abbott Northwestern Hospital
Minneapolis
Nebraska
Nebraska Medicine
Omaha
Nevada
Desert Springs Hospital Medical Center
Las Vegas
New York
North Shore University Hospital
Manhasset
Columbia University Medical Center/NewYork Presbyterian Hospital
New York
NYU Langone Medical Center
New York
Saint Joseph's Hospital Health Center
Syracuse
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Tennessee
Baptist Memorial Hospital-Memphis
Memphis
TriStar Centennial Medical Center
Nashville
Texas
Houston Methodist Hospital
Houston
Virginia
University of Virginia Medical Center
Charlottesville
Wisconsin
Saint Vincent Hospital (Green Bay WI)
Green Bay
Other Locations
Belgium
C.H.U. de Charleroi
Charleroi
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk
France
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besancon
CHU Toulouse - Hôpital Rangueil
Toulouse
Slovakia
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banska Bystrica
Time Frame
Start Date: March 30, 2017
Completion Date: August 18, 2022
Participants
Target number of participants: 416
Treatments
Primary Cohort
Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.
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.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular

This content was sourced from clinicaltrials.gov

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