RESOLUTE ONYX Post-Approval Study
ONYX PAS
A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
1 other identifier
observational
416
4 countries
28
Brief Summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2022
CompletedNovember 22, 2023
November 1, 2023
1.6 years
February 21, 2017
November 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Acute Success (Device, Lesion, Procedure)
30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
30 days and 6, 12, 24, and 36 months post-procedure
- +5 more secondary outcomes
Study Arms (2)
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.
Interventions
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Eligibility Criteria
The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.
You may qualify if:
- 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
You may not qualify if:
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Huntsville Hospital
Huntsville, Alabama, 35801-4421, United States
Scripps Green Hospital
La Jolla, California, 92037-1027, United States
Riverside Community Hospital
Riverside, California, 92501-4135, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060-1101, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109-5000, United States
Mercy Hospital (Coon Rapids MN)
Coon Rapids, Minnesota, 55433, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Desert Springs Hospital Medical Center
Las Vegas, Nevada, 89119, United States
North Shore University Hospital
Manhasset, New York, 11030-3816, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, 13203-1898, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
Houston Methodist Hospital
Houston, Texas, 77030-2703, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Saint Vincent Hospital (Green Bay WI)
Green Bay, Wisconsin, 54301, United States
C.H.U. de Charleroi
Charleroi, 6042, Belgium
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, 3600, Belgium
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU Toulouse - Hôpital Rangueil
Toulouse, 50032 31059, France
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, 97401, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2017
First Posted
February 24, 2017
Study Start
March 30, 2017
Primary Completion
October 20, 2018
Study Completion
August 18, 2022
Last Updated
November 22, 2023
Record last verified: 2023-11