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Completed

NCT Number: NCT03647475

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)

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph's Hospital Health Center, East Syracuse, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

Combination 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.

Primary outcomes

  1. 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]

Secondary outcomes

  1. Number of Participants With Target Lesion Failure

    Time frame: One Month to One Year

    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

  2. Number of Participants With Procedure Success

    Time frame: Procedure to hospital discharge, an average of 1.3 days

    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. All Participants Deaths Including Cardiac Death

    Time frame: One Month to One Year

    All participants deaths including cardiac death

  4. Number of Patients With Major Cardiac Event

    Time frame: One Month to One Year

    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. Number of Patients With Myocardial Infarction

    Time frame: One Month to One Year

    All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

  6. Number of Patients With Target Vessel Failure

    Time frame: One Month to One Year

    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. Number of Patients With Revascularization

    Time frame: One Month to One Year

    All revascularizations (TLR, TVR and non-TVR)

  8. Number of Patients With Stent Thrombosis

    Time frame: One Month to One Year

    Stent thrombosis (per Academic Research Consortium (ARC) definition)

  9. Number of Patients With Bleeding

    Time frame: One Month to One Year

    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

  10. Number of Patients With Stroke

    Time frame: One Month to One Year

    Stroke

  11. Lesion Success

    Time frame: End of Procedure, an average of 42 minutes

    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: End of Procedure an average of 42 minutes

    Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study 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)

Acronym: Onyx ONE Clear

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 27, 2018
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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