Coronary Artery DiseaseNCT02412501
Medtronic Resolute Onyx 2.0 mm Clinical Study
A study testing Resolute Onyx Stent - 2.0 mm in people with Coronary Artery Disease, run by Medtronic Vascular at 17 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 that allows the use of a 2.0 mm diameter stent. 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 - 2.0 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 17 sitesUnited States
- Study dates
- 6 Apr 2015to 21 Feb 2019
- 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, stenting, \& emergent coronary artery bypass graft (CABG) surgery
- Must have evidence of ischemic heart disease
- Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
- 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
AnMed Health Medical Center
Anderson, South Carolina, 29621
Morton Plant Hospital
Clearwater, Florida, 33756
Dallas VA Medical Center
Dallas, Texas, 75216
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University Medical Center
Durham, North Carolina, 27705
University Hospitals Elyria Medical Center
Elyria, Ohio, 44035
Sanford Medical Center
Fargo, North Dakota, 58102
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Scripps Green Hospital
La Jolla, California, 92037
Centennial Medical Center
Nashville, Tennessee, 37205
NYU Langone Medical Center
New York, New York, 10016
The Mount Sinai Medical Center
New York, New York, 10029
Saint Francis Hospital
Roslyn, New York, 11576
Saint John's Hospital
Springfield, Illinois, 62701
Barnes Jewish University
St Louis, Missouri, 63110
East Texas Medical Center
Tyler, Texas, 75701
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 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 that allows the use of a 2.0 mm diameter stent.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Onyx Stent - 2.0 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 - 2.0 mmDevice
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
| Study group | Role | What they receive |
|---|---|---|
| Device | Other | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent Receives: Device: Resolute Onyx Stent - 2.0 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
Measured: 12 Months
Secondary outcomes (17)
Number of Participants With Cardiac Death at 12 Months Post Procedure
Measured: 12 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Measured: 12 Months
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
Measured: 12Months
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
Measured: 24 Months
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
Measured: 12 Months
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
Measured: 12 Months
Number of Participants With Cardiac Death at 24 Months Post Procedure
Measured: 24 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Measured: 24 Months
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
Measured: 24 Months
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
Measured: 24 Months
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
Measured: 24 Months
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
Measured: 36 Months
Number of Participants With Cardiac Death at 36 Months Post Procedure
Measured: 36 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Measured: 36 Months
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
Measured: 36 Months
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
Measured: 36 Months
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start6 Apr 2015
- Primary completion13 Feb 2017
- Study completion21 Feb 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 101 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 HospitalShigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412501
- Sponsor's protocol ID
- Version 5.0 - 26Mar2015
- Status last verified
- Jun 2019
- First submitted
- 6 Apr 2015
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Price MJ, Saito S, Shlofmitz RA, Spriggs DJ, Attubato M, McLaurin B, Popma Almonacid A, Brar S, Liu M, Moe E, Mehran R. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.
PubMed 28728650
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 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 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study
- ClinicalTrials.gov ID
- NCT02412501
- Acronym / sponsor ID
- Version 5.0 - 26Mar2015
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2015 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 10 Apr 2018
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 that allows the use of a 2.0 mm diameter stent.
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 - 2.0 mmMedtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent |
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, stenting, \& emergent coronary artery bypass graft (CABG) surgery
- Must have evidence of ischemic heart disease
- Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
- 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 - 2.0 mmClinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent | Device | Device |
Primary outcome
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
Time frame: 12 Months
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
17 secondary outcomes
Number of Participants With Cardiac Death at 12 Months Post Procedure
Time frame: 12 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
Time frame: 12 Months
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
Time frame: 12Months
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
Time frame: 12 Months
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
Time frame: 12 Months
Number of Participants With Cardiac Death at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
Time frame: 24 Months
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
Time frame: 36 Months
Number of Participants With Cardiac Death at 36 Months Post Procedure
Time frame: 36 Months
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
Time frame: 36 Months
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
Time frame: 36 Months
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
Time frame: 36 Months
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28728650Price MJ, Saito S, Shlofmitz RA, Spriggs DJ, Attubato M, McLaurin B, Popma Almonacid A, Brar S, Liu M, Moe E, Mehran R. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.
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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
Shigeru Saito, MD principal investigator
Shonan Kamakura General Hospital
17 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 - 2.0 mm in people with Coronary Artery Disease, run by Medtronic Vascular at 17 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 10 Apr 2018). 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 Lesion Failure at 12 Months Post-Procedure (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412501, which also lists 1 linked publication.
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 2 Jul 2019.