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A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03344653
Acronym
Onyx ONE
Enrollment
2000
Registered
2017-11-17
Start date
2017-11-02
Completion date
2020-10-09
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

The purpose of this study 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.

Interventions

DEVICEMedtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT

DEVICEBiosensors BioFreedom BA9 Drug Coated Coronary Stent

Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

Sponsors

Medtronic Vascular
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis1 year post-procedurePowered 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

Secondary

MeasureTime frameDescription
Procedure Success2 year post-procedureAttainment 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 Death2 year post- procedureAll deaths including cardiac death
Major Cardiac Event2 year post- procedureMajor adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Myocardial Infarction2 year post-procedureAll myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Target Vessel Failure2 year post-procedureTarget 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.
Target Lesion Failure2 year post-procedureDefined 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
Stent Thrombosis2 year post-procedureStent thrombosis (per Academic Research Consortium (ARC) definition)
Bleeding2 year post-procedureBleeding per BARC criteria
Stroke2 year post-procedureStroke
Lesion Success2 year post-procedureThe attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Device success2 year post-procedureAttainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Revascularization2 year post-procedureAll revascularizations (TLR, TVR and non-TVR)

Countries

Australia, Austria, Belgium, Bulgaria, France, Hong Kong, Ireland, Italy, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026