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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:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00556426
First received: November 8, 2007
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556426

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

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00556426     History of Changes
Other Study ID Numbers: BPV-RC-1332
Study First Received: November 8, 2007
Results First Received: May 26, 2009
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

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
Thrombosis

ClinicalTrials.gov processed this record on May 19, 2013