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OpenTrials
Completed

NCT Number: NCT00556426

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

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases Venous Thromboembolic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bard Recovery G2 Filter System

Device

Retrieval of previously placed RECOVERY G2 IVC filter

Other names: Bard Recovery G2 Filter

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study 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.

Acronym: EVEREST

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 12, 2007
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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