Coronary Artery DiseaseONYX PASNCT03063749
RESOLUTE ONYX Post-Approval Study
An observational study of Coronary Artery Disease, run by Medtronic Vascular at 28 sites in 4 countries.
Trial summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 416 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 30 Mar 2017to 18 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.
Who may be able to join
- 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
Who cannot join
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
United States23 sites
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109-5000
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Mercy Hospital (Coon Rapids MN)
Coon Rapids, Minnesota, 55433
North Florida Regional Medical Center
Gainesville, Florida, 32605
Saint Vincent Hospital (Green Bay WI)
Green Bay, Wisconsin, 54301
Hartford Hospital
Hartford, Connecticut, 06106
Houston Methodist Hospital
Houston, Texas, 77030-2703
Huntsville Hospital
Huntsville, Alabama, 35801-4421
Scripps Green Hospital
La Jolla, California, 92037-1027
Desert Springs Hospital Medical Center
Las Vegas, Nevada, 89119
North Shore University Hospital
Manhasset, New York, 11030-3816
WellStar Kennestone Hospital
Marietta, Georgia, 30060-1101
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
NYU Langone Medical Center
New York, New York, 10016
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
Nebraska Medicine
Omaha, Nebraska, 68105
Riverside Community Hospital
Riverside, California, 92501-4135
Saint Joseph's Hospital Health Center
Syracuse, New York, 13203-1898
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Belgium2 sites
C.H.U. de Charleroi
Charleroi, 6042
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, 3600
France2 sites
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, 25030
CHU Toulouse - Hôpital Rangueil
Toulouse, 50032 31059
Slovakia1 site
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, 97401
About this study
Official title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDevice
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDevice
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort. Receives: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | |
| 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. Receives: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Acute Success (Device, Lesion, Procedure)
Acute Success (Device, Lesion, Procedure)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
Cardiac Death
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
Target Vessel Myocardial Infarction (TVMI)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
Target Lesion Revascularization (TLR)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI
Cardiac Death and TVMI
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
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
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Failure (TLF)
Target Lesion Failure (TLF)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)
Target Vessel Failure (TVF)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)
Stent Thrombosis (ST)
Measured: 30 days and 6, 12, 24, and 36 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start30 Mar 2017
- Primary completion20 Oct 2018
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063749
- Sponsor's protocol ID
- MDT16025RES003
- Acronym
- ONYX PAS
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2017
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- ClinicalTrials.gov ID
- NCT03063749
- Acronym / sponsor ID
- ONYX PAS / MDT16025RES003
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | – | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemSubjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort. |
| Extra Large Vessel (XLV) Cohort. | – | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemSubjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The device will be used in subjects meeting the inclusion and exclusion criteria according to the Instructions for Use.
Key inclusion criteria (2 listed)
- 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 (2 listed)
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemMedtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm | Device | Primary Cohort |
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemMedtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm | Device | Extra Large Vessel (XLV) Cohort. |
Primary outcome
Target Lesion Failure
Time frame: 12 months
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
10 secondary outcomes
Acute Success (Device, Lesion, Procedure)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Myocardial Infarction (TVMI)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Revascularization (TLR)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Revascularization (TVR)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Cardiac Death and TVMI
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Major Adverse Cardiac Event (MACE)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Lesion Failure (TLF)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Target Vessel Failure (TVF)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Stent Thrombosis (ST)
Time frame: 30 days and 6, 12, 24, and 36 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Medtronic Vascular at 28 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Belgium, France, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.