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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014