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Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. (EVEREST)

Primary Purpose

Pulmonary Embolism, Venous Thromboembolic Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bard Recovery G2 Filter System
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism

Eligibility Criteria

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

Inclusion Criteria:

  • The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption

Exclusion Criteria:

  • The patient has implanted filter in the IVC or superior vena cava (SVC)
  • The patient has a duplicated or left-sided IVC
  • The patient has a known untreatable or uncontrollable malignancy
  • The patient has severe spinal deformity
  • The patient has a creatinine > 2.0 mg/dl
  • The patient has a life expectancy of < 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Filter

    Arm Description

    All subjects enrolled to the study are in this arm. All subjects receive a filter.

    Outcomes

    Primary Outcome Measures

    Technical Success (Retrieval)
    Technical success for retrieval of the filter such that the entire filter is removed.
    Clinical Success (Retrieval)
    technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
    Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
    Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure

    Secondary Outcome Measures

    Filter Migration > 2cm
    Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.
    Incidence of Filter Fracture
    occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)

    Full Information

    First Posted
    November 8, 2007
    Last Updated
    May 25, 2012
    Sponsor
    C. R. Bard
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00556426
    Brief Title
    Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.
    Acronym
    EVEREST
    Official Title
    The Bard® Recovery® Filter Registry (EVEREST) for Patients Who Are Candidates for an Optional (Retrievable) Inferior Vena Cava Filter That Undergo Placement of the Bard® Recovery® Filter.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    C. R. Bard

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Embolism, Venous Thromboembolic Disease
    Keywords
    Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Filter
    Arm Type
    Experimental
    Arm Description
    All subjects enrolled to the study are in this arm. All subjects receive a filter.
    Intervention Type
    Device
    Intervention Name(s)
    Bard Recovery G2 Filter System
    Other Intervention Name(s)
    Bard Recovery G2 Filter
    Intervention Description
    Retrieval of previously placed RECOVERY G2 IVC filter
    Primary Outcome Measure Information:
    Title
    Technical Success (Retrieval)
    Description
    Technical success for retrieval of the filter such that the entire filter is removed.
    Time Frame
    1 month post filter retrieval or through 6 months following implantation
    Title
    Clinical Success (Retrieval)
    Description
    technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
    Time Frame
    Time of Retrieval or through 6 months of implantation
    Title
    Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
    Description
    Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure
    Time Frame
    30 days post retrieval
    Secondary Outcome Measure Information:
    Title
    Filter Migration > 2cm
    Description
    Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.
    Time Frame
    30 days post retrieval or 6 months following filter placement
    Title
    Incidence of Filter Fracture
    Description
    occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)
    Time Frame
    at 6 months or at retrieval of the filter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption Exclusion Criteria: The patient has implanted filter in the IVC or superior vena cava (SVC) The patient has a duplicated or left-sided IVC The patient has a known untreatable or uncontrollable malignancy The patient has severe spinal deformity The patient has a creatinine > 2.0 mg/dl The patient has a life expectancy of < 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John A Kaufman, MD
    Organizational Affiliation
    OHSU, Portland, Oregon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.

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