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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 : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
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
Official Title: 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)
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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]


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Number of Patients with Cardiac Death [ Time Frame: 2 year post-procedure ]
    All deaths including cardiac death

  4. 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

  5. Number of Patients with Myocardial Infarction [ Time Frame: 2 year post-procedure ]
    All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

  6. 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.

  7. Number of Patients with Revascularization [ Time Frame: 2 year post-procedure ]
    All revascularizations (TLR, TVR and non-TVR)

  8. Number of Patients with Stent Thrombosis [ Time Frame: 2 year post-procedure ]
    Stent thrombosis (per Academic Research Consortium (ARC) definition)

  9. Number of Patients with Bleeding [ Time Frame: 2 year post-procedure ]
    Bleeding per BARC criteria

  10. Number of Patients with Stroke [ Time Frame: 2 year post-procedure ]
    Stroke

  11. 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

  12. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647475


Locations
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United States, New York
Saint Joseph's Hospital Health Center
East Syracuse, New York, United States, 13057
New York- Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
United States, South Carolina
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Medtronic Vascular
Investigators
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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

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03647475     History of Changes
Other Study ID Numbers: MDT18015RES008
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs