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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556426
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : May 11, 2011
Last Update Posted : June 1, 2012
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Venous Thromboembolic Disease Device: Bard Recovery G2 Filter System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Arm Intervention/treatment
Experimental: Filter
All subjects enrolled to the study are in this arm. All subjects receive a filter.
Device: Bard Recovery G2 Filter System
Retrieval of previously placed RECOVERY G2 IVC filter
Other Name: Bard Recovery G2 Filter

Primary Outcome Measures :
  1. Technical Success (Retrieval) [ Time Frame: 1 month post filter retrieval or through 6 months following implantation ]
    Technical success for retrieval of the filter such that the entire filter is removed.

  2. Clinical Success (Retrieval) [ Time Frame: Time of Retrieval or through 6 months of implantation ]
    technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.

  3. Percentage of Participants With Adverse Events Through 30 Days Post Retrieval [ Time Frame: 30 days post retrieval ]
    Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure

Secondary Outcome Measures :
  1. Filter Migration > 2cm [ Time Frame: 30 days post retrieval or 6 months following filter placement ]
    Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.

  2. Incidence of Filter Fracture [ Time Frame: at 6 months or at retrieval of the filter ]
    occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556426

Sponsors and Collaborators
C. R. Bard
Principal Investigator: John A Kaufman, MD OHSU, Portland, Oregon

Responsible Party: C. R. Bard Identifier: NCT00556426     History of Changes
Other Study ID Numbers: BPV-RC-1332
First Posted: November 12, 2007    Key Record Dates
Results First Posted: May 11, 2011
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by C. R. Bard:
Venous Thromboembolic Disease
IVC Filter
Pulmonary Embolism

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases