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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)

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ClinicalTrials.gov Identifier: NCT03344653
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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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.

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 Design
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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
Estimated Study Completion Date : August 30, 2021

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Cardiac Death [ Time Frame: 2 year post- procedure ]
    All deaths including cardiac death

  4. 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

  5. Myocardial Infarction [ Time Frame: 2 year post-procedure ]
    All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

  6. 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.

  7. Revascularization [ Time Frame: 2 year post-procedure ]
    All revascularizations (TLR, TVR and non-TVR)

  8. Stent Thrombosis [ Time Frame: 2 year post-procedure ]
    Stent thrombosis (per Academic Research Consortium (ARC) definition)

  9. Bleeding [ Time Frame: 2 year post-procedure ]
    Bleeding per BARC criteria

  10. Stroke [ Time Frame: 2 year post-procedure ]
    Stroke

  11. 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

  12. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


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Sponsors and Collaborators
Medtronic Vascular
Investigators
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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
More Information
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03344653     History of Changes
Other Study ID Numbers: MDT17054RES007
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases