Pulmonary Embolism
Conditions
Keywords
Pulmonary embolism (PE), Deep vein thrombosis (DVT), Vena cava, Vena cava filter, Inferior vena cava, Venous thromboembolic disease (VTED)
Brief summary
The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center study which is intended to provide evidence of safety of the placement and retrieval of the Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).
Interventions
The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject or their legally authorized representative demonstrates understanding of the nature of the study and voluntarily provides written informed consent prior to any data collection or study procedures. * The subject is ≥ 21 years old, must be either a male or non-pregnant female with an expected lifespan sufficient to allow for completion of all study procedures. A negative pregnancy test result (urine or blood) is required prior to implant. If an enrolled female becomes pregnant prior to study completion, participation in the study will be terminated. * Based on Investigator judgment, the subject is at increased risk of PE requiring vena caval interruption. Note: Subjects diagnosed with acute DVT and/or PE must have objective confirmation based on imaging evidence of at least one of those diagnoses. * Patients without PE or venous thromboembolic disease (VTED) who are at risk of PE may be enrolled in this trial. However, enrollment of these patients will be limited to a maximum of 40% of the total sample size. * Based on Investigator's judgment, the subject has patent venous anatomy suitable for femoral or jugular/subclavian access for filter placement (e.g. no excessive tortuosity). * The IVC is ≤ 28 mm in diameter at the intended implantation site based on radiographic imaging evidence. * Based on Investigator's judgment, the filter can be safely placed such that the position of the filter tip is 1 cm below the lowest renal vein. * Retrieval of the filter is expected within 180 days post placement. At the six month follow up, if the Investigator determines that the filter continues to be clinically indicated, the filter may be left in place until the risk of PE has passed or left in permanently. All patients not having their filter retrieved at six months will continue be followed to 24 months or one month post filter retrieval, whichever comes first. * The subject has patent venous anatomy suitable for jugular access for retrieval of the filter based on imaging evidence within 48 hours prior to the filter placement procedure. Imaging mode will be at physician's discretion. * The subject is willing to comply with the protocol requirements and specified follow-up evaluations.
Exclusion criteria
* The subject has a previously implanted filter in the IVC or superior vena cava (SVC). * The subject has a duplicated or left-sided IVC. * The subject has a severe spinal deformity that would impede access to the IVC for the filter placement or filter retrieval procedures. * The subject has a serum creatinine ≥ 2 mg/dl (and not on dialysis) within seven days of study enrollment. Patients on dialysis are allowed to participate in this trial. * The subject has a known uncorrectable bleeding diathesis or active coagulopathy. * The subject has a life expectancy of \< 25 months. * The subject has a known allergy or sensitivity to nickel or titanium. * The subject has a known allergy or sensitivity to iodinated contrast media, which cannot be adequately pre-medicated. NOTE: Alternative contrast agents are not permitted for the purposes of this study. * The subject is currently participating in an investigational drug or another device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of Placement | 6 months | Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism. |
| Clinical Success of Placement | 6 months | Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement. |
| Technical Success of Retrieval | 24 months | Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact. |
| Clinical Success of Retrieval | 24 months | Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Filter Tilt at Placement | Post-placement imaging | Rate of filter indwell complications of: tilt \>15° |
| Filter Tilt at Retrieval | Pre-retrieval imaging | Rate of filter indwell complications of: tilt \>15° |
| Rate of Recurring Pulmonary Embolism | 24 months | Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval. |
| Filter Penetration >3mm at Retrieval | Pre-retrieval | — |
| Filter Penetration >3mm at Placement | Post-placement | — |
| Rate of New or Worsening Deep Vein Thrombosis | 6 months | Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit. |
| Filter Fracture | 6 months | Rate of filter fracture |
| Filter Migration | 6 months | Rate of filter indwell complications of: migration \>2cm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Characteristics All treated with Denali filter. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 21 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Baseline Characteristics |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 15.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 164 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 138 / 200 |
| serious Total, serious adverse events | 90 / 200 |
Outcome results
Primary
Clinical Success of Placement
Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.
Time frame: 6 months
Population: The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Clinical Success of Placement | 95.2 percentage of participants |
Primary
Clinical Success of Retrieval
Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Clinical Success of Retrieval | 99.2 percentage of participants |
Primary
Technical Success of Placement
Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Technical Success of Placement | 99.5 percentage of participants |
Primary
Technical Success of Retrieval
Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.
Time frame: 24 months
Population: The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Technical Success of Retrieval | 97.6 percentage of participants |
Secondary
Filter Fracture
Rate of filter fracture
Time frame: 6 months
Population: The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Fracture | 0 percentage of participants |
Secondary
Filter Migration
Rate of filter indwell complications of: migration \>2cm.
Time frame: 6 months
Population: The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Migration | 0 percentage of participants |
Secondary
Filter Penetration >3mm at Placement
Time frame: Post-placement
Population: Penetration at Placement was measured immediately post-placement but prior to retrieval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Penetration >3mm at Placement | 1.5 percentage of participants |
Secondary
Filter Penetration >3mm at Retrieval
Time frame: Pre-retrieval
Population: The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Penetration >3mm at Retrieval | 1.6 percentage of participants |
Secondary
Filter Tilt at Placement
Rate of filter indwell complications of: tilt \>15°
Time frame: Post-placement imaging
Population: Tilt was measured post-placement with vena cavagram.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Tilt at Placement | 0 percentage of participants |
Secondary
Filter Tilt at Retrieval
Rate of filter indwell complications of: tilt \>15°
Time frame: Pre-retrieval imaging
Population: All patients undergoing a retrieval procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Filter Tilt at Retrieval | 0 percentage of participants |
Secondary
Rate of New or Worsening Deep Vein Thrombosis
Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.
Time frame: 6 months
Population: The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Rate of New or Worsening Deep Vein Thrombosis | 10.1 percentage of participants |
Secondary
Rate of Recurring Pulmonary Embolism
Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Technical Success of Placement | Rate of Recurring Pulmonary Embolism | 3.0 percentage of participants |