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TandemHeart to Reduce Infarct Size (TRIS Trial) (TRIS)

Primary Purpose

Acute Myocardial Infarction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TandemHeart System
Percutaneous coronary intervention
Sponsored by
CardiacAssist, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial infarction, STEMI, ST elevation MI, Acute MI

Eligibility Criteria

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

INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.

  1. ≥ 18 years of age
  2. Presents within 6 hours of acute MI symptoms
  3. Evidence of ST elevation
  4. First myocardial infarction
  5. Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.

  1. Contraindications to antiplatelet/anticoagulation therapy
  2. History of blood disorders or active bleeding
  3. Renal dysfunction or failure
  4. Neurologic damage
  5. Cardiogenic shock
  6. History of cerebrovascular disease
  7. History of transfusion reaction
  8. Prior coronary artery bypass surgery
  9. Participation in another trial with an investigational drug or device
  10. Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TandemHeart System + PCI

    PCI

    Arm Description

    TandemHeart System prior to percutaneous coronary intervention

    Percutaneous coronary intervention

    Outcomes

    Primary Outcome Measures

    Primary Safety
    Major Adverse Cardiac or Cerebrovascular Events (MACCE): Death, all cause Stroke Reinfarction Major vascular complications

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2014
    Last Updated
    December 3, 2015
    Sponsor
    CardiacAssist, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02164058
    Brief Title
    TandemHeart to Reduce Infarct Size (TRIS Trial)
    Acronym
    TRIS
    Official Title
    A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    February 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CardiacAssist, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction
    Keywords
    Myocardial infarction, STEMI, ST elevation MI, Acute MI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TandemHeart System + PCI
    Arm Type
    Experimental
    Arm Description
    TandemHeart System prior to percutaneous coronary intervention
    Arm Title
    PCI
    Arm Type
    Active Comparator
    Arm Description
    Percutaneous coronary intervention
    Intervention Type
    Device
    Intervention Name(s)
    TandemHeart System
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous coronary intervention
    Other Intervention Name(s)
    PCI
    Primary Outcome Measure Information:
    Title
    Primary Safety
    Description
    Major Adverse Cardiac or Cerebrovascular Events (MACCE): Death, all cause Stroke Reinfarction Major vascular complications
    Time Frame
    30 days post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION CRITERIA The following is a list of general inclusion criteria. More detailed information can be found in the study protocol. ≥ 18 years of age Presents within 6 hours of acute MI symptoms Evidence of ST elevation First myocardial infarction Written informed consent EXCLUSION CRITERIA The following is a list of general exclusion criteria. More detailed information can be found in the study protocol. Contraindications to antiplatelet/anticoagulation therapy History of blood disorders or active bleeding Renal dysfunction or failure Neurologic damage Cardiogenic shock History of cerebrovascular disease History of transfusion reaction Prior coronary artery bypass surgery Participation in another trial with an investigational drug or device Pregnant

    12. IPD Sharing Statement

    Learn more about this trial

    TandemHeart to Reduce Infarct Size (TRIS Trial)

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