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Stereotaxis and Chronic Total Occlusion

Primary Purpose

Chronic Total Coronary Occlusion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic wire navigation
Conventional wire navigation
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Total Coronary Occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • symptomatic
  • preserved wall motion or viable myocardium
  • chronic total occlusion

Exclusion Criteria:

  • chronic renal failure
  • prior allergic reactions against contrast agent
  • hyperthyreosis
  • claustrophobia
  • pregnancy
  • contraindications to aspirin or clopidogrel

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stereotaxis

    Conventional

    Arm Description

    Magnetic wire navigation

    Conventional wire navigation

    Outcomes

    Primary Outcome Measures

    level of contrast medium

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2013
    Last Updated
    November 4, 2013
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01980537
    Brief Title
    Stereotaxis and Chronic Total Occlusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares magnetic with conventional wire navigation for recanalization of CTOs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Total Coronary Occlusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stereotaxis
    Arm Type
    Experimental
    Arm Description
    Magnetic wire navigation
    Arm Title
    Conventional
    Arm Type
    Active Comparator
    Arm Description
    Conventional wire navigation
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic wire navigation
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional wire navigation
    Primary Outcome Measure Information:
    Title
    level of contrast medium
    Time Frame
    8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: symptomatic preserved wall motion or viable myocardium chronic total occlusion Exclusion Criteria: chronic renal failure prior allergic reactions against contrast agent hyperthyreosis claustrophobia pregnancy contraindications to aspirin or clopidogrel

    12. IPD Sharing Statement

    Learn more about this trial

    Stereotaxis and Chronic Total Occlusion

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