Coronary Artery DiseaseOnyx ONE ClearNCT03647475

A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

A study testing Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT in people with Coronary Artery Disease, run by Medtronic Vascular at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation. 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?: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 752 participants
Where: 4 sitesUnited States
Study dates: 1 Oct 2018to 22 Apr 2021
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

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
Any prior documented intracerebral bleed
Any documented stroke in the last 12 months

Show all 14Show fewer

Hospital admission for bleeding during the prior 12 months
Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
Planned surgery that would require interruption of DAPT (within the next 12 months)
Renal failure defined as: Creatinine clearance <40 ml/min
Thrombocytopenia (PLT <100,000/mm3)
Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
Expected non-compliance for at least 6 months DAPT for other medical reasons

Who cannot join

Pregnant and breastfeeding women
Subjects requiring a planned PCI procedure after 1 month of index procedure
Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
Active bleeding at the time of inclusion
Cardiogenic shock
Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure

Show all 11Show fewer

Subject not expected to comply with long-term single antiplatelet therapy
A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
Participation in another clinical study within 12 months after index procedure
Subjects with life expectancy of less than 2 years

Trial locations and contacts

4 sites in 1 country.

United States4 sites

AnMed Health Medical Center
Anderson, South Carolina, 29621
Saint Joseph's Hospital Health Center
East Syracuse, New York, 13057
Houston Methodist Hospital
Houston, Texas, 77030
New York- Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

Conditions: Coronary Artery Disease
Being tested: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
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.

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTCombination product
To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Study groups in NCT03647475
Study group	Role	What they receive
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Experimental	Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Receives: Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]
Measured: One Month to one year

Secondary outcomes (12)

Number of Participants With Target Lesion Failure
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 method
Measured: One Month to One Year
Number of Participants With Procedure Success
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
Measured: Procedure to hospital discharge, an average of 1.3 days
All Participants Deaths Including Cardiac Death
All participants deaths including cardiac death
Measured: One Month to One Year
Number of Patients With Major Cardiac Event
Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Measured: One Month to One Year
Number of Patients With Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Measured: One Month to One Year
Number of Patients With Target Vessel Failure
Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Measured: One Month to One Year
Number of Patients With Revascularization
All revascularizations (TLR, TVR and non-TVR)
Measured: One Month to One Year
Number of Patients With Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Measured: One Month to One Year
Number of Patients With Bleeding
Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe.
Grouping of BARC categories:
- BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories
- BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories
- All BARC- This included all bleeding events BARC 1 through BARC 5
Measured: One Month to One Year
Number of Patients With Stroke
Stroke
Measured: One Month to One Year
Lesion Success
The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Measured: End of Procedure, an average of 42 minutes
Device Success
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Measured: End of Procedure an average of 42 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201822 Apr 2021

First posted27 Aug 2018
Study start1 Oct 2018
Primary completion10 Mar 2020
Study completion22 Apr 2021

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 (3)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
Model description: Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.
Masking: None (open label)
Enrolment: 752 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03647475
Sponsor's protocol ID: MDT18015RES008
Acronym: Onyx ONE Clear
Status last verified: Oct 2021
First submitted: 17 Aug 2018
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.
PubMed 33167705
Kang J, Abdul Ghapar AK, Selvaraj K, Hur SH, Tam CC, Jang Y, Chae IH, Kandzari DE, Kirtane AJ, Latib A, Kedhi E, Lung TH, You SJ, Windecker S, Stone GW, Kim HS. One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary Intervention - Onyx ONE Clear 2-Year Results. Circ Rep. 2024 Jul 6;6(8):333-340. doi: 10.1253/circrep.CR-24-0037. eCollection 2024 Aug 9.
PubMed 39132335
Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
PubMed 37550123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
ClinicalTrials.gov ID: NCT03647475
Acronym / sponsor ID: Onyx ONE Clear / MDT18015RES008
Conditions: Coronary Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 752 participants (actual)
Lead sponsor: Medtronic VascularIndustry (pharma, biotech, devices)
Study start: 1 Oct 2018 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 22 Apr 2021 (actual)
First posted: 27 Aug 2018 (actual)
Results: Posted 6 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.

Arm	Type	Receives
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	Experimental	Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTSubjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
Any prior documented intracerebral bleed

Key exclusion criteria (11 listed)

Pregnant and breastfeeding women
Subjects requiring a planned PCI procedure after 1 month of index procedure
Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
Active bleeding at the time of inclusion
Cardiogenic shock

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
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTTo evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.	Combination product	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

Primary outcome

Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Time frame: One Month to one year
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]

12 secondary outcomes

Number of Participants With Target Lesion Failure
Time frame: One Month to One Year
Number of Participants With Procedure Success
Time frame: Procedure to hospital discharge, an average of 1.3 days
All Participants Deaths Including Cardiac Death
Time frame: One Month to One Year
Number of Patients With Major Cardiac Event
Time frame: One Month to One Year
Number of Patients With Myocardial Infarction
Time frame: One Month to One Year
Number of Patients With Target Vessel Failure
Time frame: One Month to One Year
Number of Patients With Revascularization
Time frame: One Month to One Year
Number of Patients With Stent Thrombosis
Time frame: One Month to One Year
Number of Patients With Bleeding
Time frame: One Month to One Year
Number of Patients With Stroke
Time frame: One Month to One Year
Lesion Success
Time frame: End of Procedure, an average of 42 minutes
Device Success
Time frame: End of Procedure an average of 42 minutes

Results and safety

Results posted to the registry on 6 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	752	75

Primary outcome: Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction

Time frame: One Month to one year. Count of participants. Unit: Participants

Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n = 1506
Value	104

Population analysed: The analysis population combines eligible subjects enrolled in the Onyx ONE US \& Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From One Month to 365 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent	591 of 1,506 (39.2%)	755 of 1,506 (50.1%)	89 of 1,506

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33167705Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.
Derived from this study: PubMed 39132335Kang J, Abdul Ghapar AK, Selvaraj K, Hur SH, Tam CC, Jang Y, Chae IH, Kandzari DE, Kirtane AJ, Latib A, Kedhi E, Lung TH, You SJ, Windecker S, Stone GW, Kim HS. One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary Intervention - Onyx ONE Clear 2-Year Results. Circ Rep. 2024 Jul 6;6(8):333-340. doi: 10.1253/circrep.CR-24-0037. eCollection 2024 Aug 9.
Derived from this study: PubMed 37550123Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
Individual participant dataSharing planned: No

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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.

David Kandzari, MD principal investigator

Piedmont Atlanta Hospital, Atlanta, GA

Ajay Kirtane, MD principal investigator

New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 11 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 6 May 2021). 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?

Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction (time frame: One Month to one year). 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 NCT03647475, which also lists 3 linked publications.

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 1 Nov 2021.