Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. (EVEREST)
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|ClinicalTrials.gov Identifier: NCT00556426|
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : May 11, 2011
Last Update Posted : June 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Venous Thromboembolic Disease||Device: Bard Recovery G2 Filter System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
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
- 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
- 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)
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
|Principal Investigator:||John A Kaufman, MD||OHSU, Portland, Oregon|