Coronary Artery DiseaseNCT02419521
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
A study testing Resolute Onyx Stent - 2.25 mm - 4.0 mm in people with Coronary Artery Disease, run by Medtronic Vascular at 12 sites in United States.
Trial summary
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm. 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 Stent - 2.25 mm - 4.0 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Jul 2015to 3 Dec 2018
- 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
- Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
- Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Who cannot join
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Concurrent medical condition with a life expectancy of less than 12 months
- Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
- Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
AnMed Health Medical Center
Anderson, South Carolina, 29621
Morton Plant Hospital
Clearwater, Florida, 33756
Dallas VA Medical Center
Dallas, Texas, 75216
Duke University Medical Center
Durham, North Carolina, 27705
University Hospitals Elyria Medical Center
Elyria, Ohio, 44035
Sanford Medical Center
Fargo, North Dakota, 58122
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Scripps Green Hospital
La Jolla, California, 92037
Centennial Medical Center
Nashville, Tennessee, 37205
Saint Francis Hospital
Roslyn, New York, 11576
Saint John's Hospital
Springfield, Illinois, 62701
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Onyx Stent - 2.25 mm - 4.0 mm
- 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 Stent - 2.25 mm - 4.0 mmDevice
| Study group | Role | What they receive |
|---|---|---|
| Device | Other | Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Receives: Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
Measured: 8 Months
Secondary outcomes (8)
Cardiac Death
Measured: 8 Months
Target Vessel Myocardial Infarction (TVMI)
Measured: 8 Months
Target Lesion Revascularization (TLR)
Measured: 8 Months
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: 8 Months
Target Lesion Failure (TLF)
Measured: 8 Months
Target Vessel Failure (TVF)
Measured: 8 Months
Stent Thrombosis (ST)
Measured: 8 Months
Cardiac Death and TVMI
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start7 Jul 2015
- Primary completion5 Jul 2016
- Study completion3 Dec 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew J. Price, MD, FACC, FSCAI, Principal investigator, Scripps Green Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419521
- Sponsor's protocol ID
- Version 2.0 - 23Mar2015
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 2015
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
- ClinicalTrials.gov ID
- NCT02419521
- Acronym / sponsor ID
- Version 2.0 - 23Mar2015
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Other | Device: Resolute Onyx Stent - 2.25 mm - 4.0 mmMedtronic Resolute Onyx Zotarolimus-Eluting Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
- Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Key exclusion criteria (8 listed)
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
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 Stent - 2.25 mm - 4.0 mm | Device | Device |
Primary outcome
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
Time frame: 8 Months
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
8 secondary outcomes
Cardiac Death
Time frame: 8 Months
Target Vessel Myocardial Infarction (TVMI)
Time frame: 8 Months
Target Lesion Revascularization (TLR)
Time frame: 8 Months
Major Adverse Cardiac Event (MACE)
Time frame: 8 Months
Target Lesion Failure (TLF)
Time frame: 8 Months
Target Vessel Failure (TVF)
Time frame: 8 Months
Stent Thrombosis (ST)
Time frame: 8 Months
Cardiac Death and TVMI
Time frame: 8 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- 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.
Matthew J. Price, MD, FACC, FSCAI principal investigator
Scripps Green Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Onyx Stent - 2.25 mm - 4.0 mm in people with Coronary Artery Disease, run by Medtronic Vascular at 12 sites in United States.
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 4 inclusion and 8 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 28 Jul 2017). 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?
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography (time frame: 8 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 3 Apr 2019.