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

May 25, 2012 updated by: C. R. Bard

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Bard Recovery G2 Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month post filter retrieval or through 6 months following implantation
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.
Time of Retrieval or through 6 months of implantation
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
30 days post retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post retrieval or 6 months following filter placement
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)
at 6 months or at retrieval of the filter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: John A Kaufman, MD, OHSU, Portland, Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 8, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 25, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPV-RC-1332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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