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Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Coronary artery bypass grafting
Percutaneous coronary intervention
Sponsored by
Teikyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.

    • Patients with multivessel coronary artery disease including significant stenotic lesion* in the right coronary artery and also including left main stem disease.
    • Patients who will be referred for CABG.
    • Patients with significant stenotic lesion in the right coronary artery amenable to PCI.
    • Patients who can take DAPT medications.
    • Patients who provided written informed consent. * Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%.

Exclusion Criteria:

  • • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.

    • Patients who previously underwent CABG.
    • Patients who are at high risk of receiving CABG.
    • Patients who need simultaneous surgery such as valve surgery other than CABG.
    • Patients with a life expectancy of 1 year or shorter due to co-morbidities.
    • Patients with a history of cerebral infarction within the last 6 months.
    • Patients with congestive cardiac failure of NYHA 3 or higher.
    • Patients with unstable hemodynamics at enrollment.
    • Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23).
    • Patients receiving long-term dialysis.
    • Patients who are allergic to antiplatelet agent.
    • Patients who are critically allergic to contrast media.
    • Patients who are allergic to any DES component.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PCI and CABG

    Arm Description

    Outcomes

    Primary Outcome Measures

    Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2016
    Last Updated
    September 8, 2016
    Sponsor
    Teikyo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02894255
    Brief Title
    Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Teikyo University

    4. Oversight

    5. Study Description

    Brief Summary
    This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.

    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
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PCI and CABG
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Coronary artery bypass grafting
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous coronary intervention
    Primary Outcome Measure Information:
    Title
    Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction. Patients with multivessel coronary artery disease including significant stenotic lesion* in the right coronary artery and also including left main stem disease. Patients who will be referred for CABG. Patients with significant stenotic lesion in the right coronary artery amenable to PCI. Patients who can take DAPT medications. Patients who provided written informed consent. * Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%. Exclusion Criteria: • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment. Patients who previously underwent CABG. Patients who are at high risk of receiving CABG. Patients who need simultaneous surgery such as valve surgery other than CABG. Patients with a life expectancy of 1 year or shorter due to co-morbidities. Patients with a history of cerebral infarction within the last 6 months. Patients with congestive cardiac failure of NYHA 3 or higher. Patients with unstable hemodynamics at enrollment. Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23). Patients receiving long-term dialysis. Patients who are allergic to antiplatelet agent. Patients who are critically allergic to contrast media. Patients who are allergic to any DES component.

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents

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