A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03344653 |
Recruitment Status :
Completed
First Posted : November 17, 2017
Last Update Posted : December 2, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months. |
Masking: | Single (Participant) |
Masking Description: | Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control). |
Primary Purpose: | Treatment |
Official Title: | Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients |
Actual Study Start Date : | November 2, 2017 |
Actual Primary Completion Date : | September 27, 2018 |
Actual Study Completion Date : | October 9, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Resolute Onyx stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
|
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT |
Active Comparator: BioFreedom stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
|
Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT |
- Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis [ Time Frame: 1 year post-procedure ]Powered for non-inferiority against BioFreedom (control), is a composite of cardiac death, myocardial infarction and definite/probable stent thrombosis. The combined clinical outcome of cardiac death, MI or stent thrombosis
- Target Lesion Failure [ Time Frame: 2 year post-procedure ]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
- Procedure Success [ Time Frame: 2 year post-procedure ]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.
- Cardiac Death [ Time Frame: 2 year post- procedure ]All deaths including cardiac death
- Major Cardiac Event [ Time Frame: 2 year post- procedure ]Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
- Myocardial Infarction [ Time Frame: 2 year post-procedure ]All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
- Target Vessel Failure [ Time Frame: 2 year post-procedure ]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.
- Revascularization [ Time Frame: 2 year post-procedure ]All revascularizations (TLR, TVR and non-TVR)
- Stent Thrombosis [ Time Frame: 2 year post-procedure ]Stent thrombosis (per Academic Research Consortium (ARC) definition)
- Bleeding [ Time Frame: 2 year post-procedure ]Bleeding per BARC criteria
- Stroke [ Time Frame: 2 year post-procedure ]Stroke
- Lesion Success [ Time Frame: 2 year post-procedure ]The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
- Device success [ Time Frame: 2 year post-procedure ]Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 75 years old
- Any prior documented intracerebral bleed
- Any documented stroke in the last 12 months
- Hospital admission for bleeding during the prior 12 months
- Non-skin cancer diagnosed or treated ≤3 years
- Planned surgery 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
Exclusion Criteria:
- Pregnant and breastfeeding women
- Subjects requiring a planned PCI procedure after 1 month of index procedure
- Active bleeding at the time of inclusion
- Cardiogenic shock
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344653

Principal Investigator: | Stephan Windecker, MD | Bern University Hospital, Bern, Switzerland | |
Principal Investigator: | Azeem Latib, MD | San Raffaele Scientific Institute, Milan, Italy | |
Principal Investigator: | Elvin Kedhi, MD | Isala Zwolle, Netherlands |
Responsible Party: | Medtronic Vascular |
ClinicalTrials.gov Identifier: | NCT03344653 |
Other Study ID Numbers: |
MDT17054RES007 |
First Posted: | November 17, 2017 Key Record Dates |
Last Update Posted: | December 2, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |