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Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms (CanFRED)

Primary Purpose

Intracranial Aneurysms

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FRED
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms

Eligibility Criteria

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

Inclusion Criteria:

  • Subject whose age is ≥ 18 years;
  • Subject has a single target aneurysm located in the following zones:
  • Zone 1 - Petrous through cavernous of the ICA
  • Zone 2 - Ophthalmic segment of the ICA
  • Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
  • Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
  • Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck
  • Fusiform aneurysms of any size requiring treatment;
  • The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
  • Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
  • Negative pregnancy test in a female subject who has had menses in the last 24 months;
  • Subject is willing to return for the 1-month and 6-month follow-up evaluations

Exclusion Criteria:

  • Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
  • Subject who suffers from any intracranial hemorrhage in the last 30 days;
  • Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
  • Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm;
  • Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
  • Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
  • Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
  • Subject with documented contrast allergy, or other condition, that prohibits imaging.
  • Evidence of active bacterial infection at the time of treatment;
  • Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
  • Subject with life-threatening diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Flow Re-Direction Endoluminal Device

    Arm Description

    Flow Re-Direction Endoluminal Device (FRED Device)

    Outcomes

    Primary Outcome Measures

    death or major stroke
    A major stroke is defined as a new neurological event that persists for > 24 hours and results in a mRS >2. A minor stroke is defined as a new neurological event that persists for > 24 hours.
    neurological death or major ipsilateral stroke, measured by mRS.

    Secondary Outcome Measures

    Incidence of FRED System and procedure related Serious Adverse Events;
    Incidence of successful delivery of the FRED System implant;
    Incidence of migration of the FRED System implant
    Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)
    Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject
    Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
    as measured by an increase in the modified Rankin Scale compared to baseline

    Full Information

    First Posted
    December 3, 2014
    Last Updated
    July 27, 2015
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02309203
    Brief Title
    Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
    Acronym
    CanFRED
    Official Title
    Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study not initiated at our site.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Flow Re-Direction Endoluminal Device
    Arm Type
    Experimental
    Arm Description
    Flow Re-Direction Endoluminal Device (FRED Device)
    Intervention Type
    Device
    Intervention Name(s)
    FRED
    Intervention Description
    Flow Re-Direction Endoluminal Device
    Primary Outcome Measure Information:
    Title
    death or major stroke
    Description
    A major stroke is defined as a new neurological event that persists for > 24 hours and results in a mRS >2. A minor stroke is defined as a new neurological event that persists for > 24 hours.
    Time Frame
    within 30 days post procedure
    Title
    neurological death or major ipsilateral stroke, measured by mRS.
    Time Frame
    within 6 months post procedure
    Secondary Outcome Measure Information:
    Title
    Incidence of FRED System and procedure related Serious Adverse Events;
    Time Frame
    1 year
    Title
    Incidence of successful delivery of the FRED System implant;
    Time Frame
    24 hours
    Title
    Incidence of migration of the FRED System implant
    Time Frame
    6 months
    Title
    Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)
    Description
    Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject
    Time Frame
    Within 6 months
    Title
    Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
    Description
    as measured by an increase in the modified Rankin Scale compared to baseline
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject whose age is ≥ 18 years; Subject has a single target aneurysm located in the following zones: Zone 1 - Petrous through cavernous of the ICA Zone 2 - Ophthalmic segment of the ICA Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics: Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck Fusiform aneurysms of any size requiring treatment; The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA); Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form; Negative pregnancy test in a female subject who has had menses in the last 24 months; Subject is willing to return for the 1-month and 6-month follow-up evaluations Exclusion Criteria: Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days; Subject who suffers from any intracranial hemorrhage in the last 30 days; Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region; Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm; Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents; Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor); Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry Subject with documented contrast allergy, or other condition, that prohibits imaging. Evidence of active bacterial infection at the time of treatment; Subject who has had a previous intracranial stenting procedure associated with the target aneurysm; Subject with life-threatening diseases.

    12. IPD Sharing Statement

    Learn more about this trial

    Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms

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