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NCT03063749 Clinical Trial

RESOLUTE ONYX Post-Approval Study

Coronary Artery Disease Clinical Trial

— ONYX PAS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03063749
Other study ID # MDT16025RES003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 30, 2017
Est. completion date August 18, 2022

Study information
Verified date November 2023
Source Medtronic Vascular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 416
Est. completion date August 18, 2022
Est. primary completion date October 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
Belgium C.H.U. de Charleroi Charleroi
Belgium Ziekenhuis Oost Limburg - Campus Sint-Jan Genk
France Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz Besancon
France CHU Toulouse - Hôpital Rangueil Toulouse
Slovakia Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s Banska Bystrica
United States University of Michigan Health System - University Hospital Ann Arbor Michigan
United States University of Virginia Medical Center Charlottesville Virginia
United States Morton Plant Hospital Clearwater Florida
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Mercy Hospital (Coon Rapids MN) Coon Rapids Minnesota
United States North Florida Regional Medical Center Gainesville Florida
United States Saint Vincent Hospital (Green Bay WI) Green Bay Wisconsin
United States Hartford Hospital Hartford Connecticut
United States Houston Methodist Hospital Houston Texas
United States Huntsville Hospital Huntsville Alabama
United States Scripps Green Hospital La Jolla California
United States Desert Springs Hospital Medical Center Las Vegas Nevada
United States North Shore University Hospital Manhasset New York
United States WellStar Kennestone Hospital Marietta Georgia
United States Baptist Memorial Hospital-Memphis Memphis Tennessee
United States Abbott Northwestern Hospital Minneapolis Minnesota
United States TriStar Centennial Medical Center Nashville Tennessee
United States Columbia University Medical Center/NewYork Presbyterian Hospital New York New York
United States NYU Langone Medical Center New York New York
United States Nebraska Medicine Omaha Nebraska
United States Riverside Community Hospital Riverside California
United States Saint Joseph's Hospital Health Center Syracuse New York
United States Tallahassee Memorial Hospital Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Belgium,  France,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target Lesion Failure Target Lesion Failure (TLF), defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods 12 months
Secondary Acute Success (Device, Lesion, Procedure) Acute Success (Device, Lesion, Procedure) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Cardiac Death Cardiac Death 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Target Vessel Myocardial Infarction (TVMI) Target Vessel Myocardial Infarction (TVMI) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Target Lesion Revascularization (TLR) Target Lesion Revascularization (TLR) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Target Vessel Revascularization (TVR) Target Vessel Revascularization (TVR) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Cardiac Death and TVMI Cardiac Death and TVMI 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Major Adverse Cardiac Event (MACE) Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Target Lesion Failure (TLF) Target Lesion Failure (TLF) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Target Vessel Failure (TVF) Target Vessel Failure (TVF) 30 days and 6, 12, 24, and 36 months post-procedure
Secondary Stent Thrombosis (ST) Stent Thrombosis (ST) 30 days and 6, 12, 24, and 36 months post-procedure
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