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) (Onyx ONE Clear)

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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Combination product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

• Study Type: Interventional
• Enrollment (Actual): 752
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • East Syracuse, New York, United States, 13057
      • Saint Joseph's Hospital Health Center
    • New York, New York, United States, 10032
      • New York- Presbyterian Hospital/Columbia University Medical Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: David Kandzari, MD, Piedmont Atlanta Hospital, Atlanta, GA; Principal Investigator: Ajay Kirtane, MD, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY

Publications and helpful links

General Publications

• Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): March 10, 2020
• Study Completion (ACTUAL): April 22, 2021

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MDT18015RES008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes