Pulmonary Embolism, Venous Thromboembolic Disease
Conditions
Keywords
Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism
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.
Interventions
DEVICEBard Recovery G2 Filter System
Retrieval of previously placed RECOVERY G2 IVC filter
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success (Retrieval) | 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 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 | 30 days post retrieval | Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Filter Migration > 2cm | 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 | 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) |
Participant flow
Recruitment details
Eleven Investigators at 11 sites enrolled a total of 100 study subjects between December 7, 2005 and July 24, 2006.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving a Filter Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants Receiving a Filter |
|---|---|
| Age Continuous | 52.1 years STANDARD_DEVIATION 16.7 |
| Indication for Placement active thromboembolic disease | 43 Number of Participants |
| Indication for Placement no active thromboembolic disease | 57 Number of Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 100 |
| serious Total, serious adverse events | 6 / 100 |
Outcome results
Primary
Clinical Success (Retrieval)
technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
Time frame: Time of Retrieval or through 6 months of implantation
Population: 61/100 patients experienced filter retrieval during the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Receiving the Filter | Clinical Success (Retrieval) | 57 participants |
Primary
Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure
Time frame: 30 days post retrieval
Population: 61 of 100 patients underwent filter retrieval during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Receiving the Filter | Percentage of Participants With Adverse Events Through 30 Days Post Retrieval | 14.8 percentage of participants |
Primary
Technical Success (Retrieval)
Technical success for retrieval of the filter such that the entire filter is removed.
Time frame: 1 month post filter retrieval or through 6 months following implantation
Population: 61 of 100 patients enrolled underwent filter retrieval during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Receiving the Filter | Technical Success (Retrieval) | 58 participants |
Secondary
Filter Migration > 2cm
Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.
Time frame: 30 days post retrieval or 6 months following filter placement
Population: Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Receiving the Filter | Filter Migration > 2cm | 12.2 Percent Subjects with Filter Migration |
Secondary
Incidence of Filter Fracture
occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)
Time frame: at 6 months or at retrieval of the filter
Population: adequate imaging was available to assess filter integrity in 83 of the 100 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients Receiving the Filter | Incidence of Filter Fracture | 1 number of fractured filters |