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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Technical Success (Retrieval)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Filter Migration > 2cm(30 days post retrieval or 6 months following filter placement)
- Incidence of Filter Fracture(at 6 months or at retrieval of the filter)