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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556426
First Posted: November 12, 2007
Last Update Posted: June 1, 2012
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.
Information provided by (Responsible Party):
C. R. Bard
  Purpose
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 Intervention
Pulmonary Embolism Venous Thromboembolic Disease Device: Bard Recovery G2 Filter System

Study Type: Interventional
Study Design: 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.

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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:
  • 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.

  • 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)


Enrollment: 100
Study Start Date: December 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00556426


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

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00556426     History of Changes
Other Study ID Numbers: BPV-RC-1332
First Submitted: November 8, 2007
First Posted: November 12, 2007
Results First Submitted: May 26, 2009
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:
Embolism
Pulmonary Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases