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A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) (Onyx ONE Clear)

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ClinicalTrials.gov Identifier: NCT03647475
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE August 17, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
Composite endpoint: Cardiac Death and Myocardial Infarction [Time Frame: One year post procedure] [ 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]
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis [ Time Frame: One month to one year. ]
Change History Complete list of historical versions of study NCT03647475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • 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 method
  • 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.
  • Number of Patients with Cardiac Death [ Time Frame: 2 year post-procedure ]
    All deaths including cardiac death
  • Number of Patients with 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
  • Number of Patients with Myocardial Infarction [ Time Frame: 2 year post-procedure ]
    All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
  • Number of Patients with 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.
  • Number of Patients with Revascularization [ Time Frame: 2 year post-procedure ]
    All revascularizations (TLR, TVR and non-TVR)
  • Number of Patients with Stent Thrombosis [ Time Frame: 2 year post-procedure ]
    Stent thrombosis (per Academic Research Consortium (ARC) definition)
  • Number of Patients with Bleeding [ Time Frame: 2 year post-procedure ]
    Bleeding per BARC criteria
  • Number of Patients with Stroke [ Time Frame: 2 year post-procedure ]
    Stroke
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Official Title  ICMJE Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, multi-center, single arm study 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)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be 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 will be evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.
Intervention: Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03647475
Other Study ID Numbers  ICMJE MDT18015RES008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Vascular
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP