Clinical trial NCT03063749: RESOLUTE ONYX Post-Approval Study
Official title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.

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


Eligibility criteria: Key Inclusion Criteria

* 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

Key Exclusion Criteria

* Unprotected left main disease
* Subjects with planned PCI of three vessel disease

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: Acute Success (Device, Lesion, Procedure)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Cardiac Death
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Target Vessel Myocardial Infarction (TVMI)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Cardiac Death and TVMI
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Target Lesion Failure (TLF)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Target Vessel Failure (TVF)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
measure: Stent Thrombosis (ST)
timeFrame: 30 days and 6, 12, 24, and 36 months post-procedure
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System - University Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital (Coon Rapids MN)
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Las Vegas
country: United States
facility: Desert Springs Hospital Medical Center
state: Nevada
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NewYork Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: Saint Joseph's Hospital Health Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Memphis
country: United States
facility: Baptist Memorial Hospital-Memphis
state: Tennessee
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital (Green Bay WI)
state: Wisconsin
city: Charleroi
country: Belgium
facility: C.H.U. de Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus Sint-Jan
city: Besancon
country: France
facility: Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Study officials:
References: