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)

Study Overview
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Brief Summary
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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.

Official Title
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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
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Coronary Artery Disease

Intervention / Treatment
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* Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent<br>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. | Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | One Month to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Procedure to hospital discharge, an average of 1.3 days | 
| All Participants Deaths Including Cardiac Death | All participants deaths including cardiac death | 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 | One Month to One Year | 
| Number of Patients With Myocardial Infarction | All myocardial infarction including Target Vessel Myocardial Infarction (TVMI) | 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. | One Month to One Year | 
| Number of Patients With Revascularization | All revascularizations (TLR, TVR and non-TVR) | One Month to One Year | 
| Number of Patients With Stent Thrombosis | Stent thrombosis (per Academic Research Consortium (ARC) definition) | 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 | One Month to One Year | 
| Number of Patients With Stroke | Stroke | 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 | 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. | End of Procedure an average of 42 minutes |