Coronary Artery DiseaseNCT03584464
RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Medtronic Vascular at 25 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. To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 14 May 2018to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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
- Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Who cannot join
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
- Planned two stent technique (main branch and side branch) of a bifurcation
- Subjects with more than one bifurcation lesion
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States21 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109-5869
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Morton Plant Hospital
Clearwater, Florida, 33756
Mercy Hospital
Coon Rapids, Minnesota, 55433-4568
St. Josephs Hospital Health Center
East Syracuse, New York, 13057-9208
North Florida Regional Medical Center
Gainesville, Florida, 32605-4524
Baptist Memorial Hospital-Memphis
Germantown, Tennessee, 38138-1727
Saint Vincent Hospital
Green Bay, Wisconsin, 54301
Hartford Hospital
Hartford, Connecticut, 06106-5527
Houston Methodist Hospital
Houston, Texas, 77030
Huntsville Hospital
Huntsville, Alabama, 35801-4421
Scripps Green Hospital
La Jolla, California, 92037
Desert Springs Hospital
Las Vegas, Nevada, 89118-3011
North Shore University Hospital
Manhasset, New York, 11030
WellStar Kennestone Hospital
Marietta, Georgia, 30060-1125
Abbott Northwestern
Minneapolis, Minnesota, 55407-1195
NYU Langone Medical Center
New York, New York, 10016
New York-Presbyterian Hospital/ Columbia University Medical Center
New York, New York, 10032-3729
Nebraska Medical Center
Omaha, Nebraska, 68198-2265
Riverside Community Hospital
Riverside, California, 92506-0102
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308-4646
Belgium2 sites
CHU Charleroi
Charleroi, 6042
Ziekenhuis Oost Limburg
Genk, 3600
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.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
- 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 - 5.0 mm
| Study group | Role | What they receive |
|---|---|---|
| Bifurcation Cohort | Other | Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation 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.
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Measured: 12 Months
Secondary outcomes (8)
Number of Participants With Cardiac Death
Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Measured: 12 months
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Measured: Up to 12 months
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
Measured: 12 months
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Measured: 12 months
Number of Participants With Cardiac Death and TVMI
Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Measured: 12 months
Number of Participants With Major Adverse Cardiac Event (MACE)
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: 12 months
Number of Participants With Target Lesion Failure (TLF)
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
Number of Participants With Stent Thrombosis (ARC) Definite/Probable
Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC).
Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.
Probable: Any unexplained death within the first 30 days.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start14 May 2018
- Primary completion4 Nov 2020
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 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
- NCT03584464
- Sponsor's protocol ID
- Ver 4.0 16Feb2018
- Status last verified
- Nov 2023
- First submitted
- 14 May 2018
- Last updated
- 24 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 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
- NCT03584464
- Acronym / sponsor ID
- Ver 4.0 16Feb2018
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 12 Jan 2022
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.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bifurcation Cohort | Other | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemSubjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
- Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Key exclusion criteria (4 listed)
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
- Planned two stent technique (main branch and side branch) of a bifurcation
- Subjects with more than one bifurcation lesion
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 - 5.0 mm | Device | Bifurcation Cohort |
Primary outcome
Number of Participants With Target Vessel Failure (TVF)
Time frame: 12 Months
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
8 secondary outcomes
Number of Participants With Cardiac Death
Time frame: 12 months
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
Time frame: Up to 12 months
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 12 months
Number of Participants With Target Vessel Revascularization (TVR)
Time frame: 12 months
Number of Participants With Cardiac Death and TVMI
Time frame: 12 months
Number of Participants With Major Adverse Cardiac Event (MACE)
Time frame: 12 months
Number of Participants With Target Lesion Failure (TLF)
Time frame: 12 months
Number of Participants With Stent Thrombosis (ARC) Definite/Probable
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Medtronic Vascular at 25 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 3 inclusion and 4 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 24 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 25 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?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Target Vessel Failure (TVF) (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 24 Nov 2023.