Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. (EVEREST)
|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|
|Pulmonary Embolism Venous Thromboembolic Disease||Device: Bard Recovery G2 Filter System|
|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|
|Primary Completion Date :||April 2007|
|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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556426
|Principal Investigator:||John A Kaufman, MD||OHSU, Portland, Oregon|