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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)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Joseph's Hospital Health Center
  • New York- Presbyterian Hospital/Columbia University Medical Center
  • AnMed Health Medical Center
  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

Arm Description

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.

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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
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.
All Participants Deaths Including Cardiac Death
All participants deaths including cardiac death
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
Number of Patients With Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
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.
Number of Patients With Revascularization
All revascularizations (TLR, TVR and non-TVR)
Number of Patients With Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
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
Number of Patients With Stroke
Stroke
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
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.

Full Information

First Posted
August 17, 2018
Last Updated
October 28, 2021
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT03647475
Brief Title
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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
Intervention Description
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 Outcome Measure Information:
Title
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Description
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [Time Frame: One month to one year]
Time Frame
One Month to one year
Secondary Outcome Measure Information:
Title
Number of Participants With Target Lesion Failure
Description
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
Time Frame
One Month to One Year
Title
Number of Participants With Procedure Success
Description
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.
Time Frame
Procedure to hospital discharge, an average of 1.3 days
Title
All Participants Deaths Including Cardiac Death
Description
All participants deaths including cardiac death
Time Frame
One Month to One Year
Title
Number of Patients With Major Cardiac Event
Description
Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Time Frame
One Month to One Year
Title
Number of Patients With Myocardial Infarction
Description
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Time Frame
One Month to One Year
Title
Number of Patients With Target Vessel Failure
Description
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.
Time Frame
One Month to One Year
Title
Number of Patients With Revascularization
Description
All revascularizations (TLR, TVR and non-TVR)
Time Frame
One Month to One Year
Title
Number of Patients With Stent Thrombosis
Description
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Time Frame
One Month to One Year
Title
Number of Patients With Bleeding
Description
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
Time Frame
One Month to One Year
Title
Number of Patients With Stroke
Description
Stroke
Time Frame
One Month to One Year
Title
Lesion Success
Description
The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Time Frame
End of Procedure, an average of 42 minutes
Title
Device Success
Description
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Time Frame
End of Procedure an average of 42 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Piedmont Atlanta Hospital, Atlanta, GA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD
Organizational Affiliation
New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph's Hospital Health Center
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
New York- Presbyterian Hospital/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AnMed Health Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33167705
Citation
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.
Results Reference
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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)

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