Deep Vein Thrombosis, Pulmonary Embolism
Conditions
Brief summary
The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).
Detailed description
Pulmonary embolism (PE) is a prevalent disease with a significant morbidity and mortality. The estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the United States. It is estimated that PE results in more than 200,000 deaths per year. Currently there are two types of commercially available IVC filters utilized to prevent PE; permanent and retrievable. Both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (DVT). Retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. In a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%. There are numerous design features of the SENTRY IVC Filter that are intended to improve on the limitations of available IVC filters and obviate the need for retrieval.
Interventions
DEVICESENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.
Sponsors
Novate Medical
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age 2. fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent 3. willing and able to comply with follow-up visit requirements 4. requirement of transient PE protection of \< 60 days 5. documented or high risk of PE or DVT 6. inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy 7. IVC diameter compatible with filter diameter 8. IVC length adequate for filter placement
Exclusion criteria
1. intellectual impairment preventing understanding involvement in a clinical study 2. hypersensitivity to device components 3. impaired renal function defined as a serum creatinine level of \> 2.0 mg/dL 4. active systemic infection 5. life expectancy \< 12 months 6. malignancy extending PE risk \> 60 days 7. pregnant or plans to become pregnant during study follow-up period 8. participating in another investigational trial that has not reached its primary endpoint 9. known hypercoaguable state 10. inherited or acquired hemostatic disorder 11. history or presence of a caval stent or filter 12. inability to gain femoral or jugular access 13. duplicated or left sided IVC 14. renal vein thrombosis or IVC thrombosis extending to the renal veins 15. jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery 16. spinal irregularity that may interfere with successful device delivery 17. occlusive or free-floating thrombus in the IVC 18. contrast allergy that cannot be adequately pre-medicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Reported Clinical Success | 6 Months | A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With IVC Filter Related Complications | 6months | IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death). |
Countries
Belgium, Chile, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SENTRY IVC Filter Group Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | SENTRY IVC Filter Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 59 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 13.52 |
| Region of Enrollment Belgium | 4 Participants |
| Region of Enrollment Chile | 10 Participants |
| Region of Enrollment United States | 115 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 85 / 129 |
| serious Total, serious adverse events | 45 / 129 |
Outcome results
Primary
Number of Subjects That Reported Clinical Success
A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SENTRY IVC Filter | Number of Subjects That Reported Clinical Success | 111 Participants |
Secondary
Number of Participants With IVC Filter Related Complications
IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).
Time frame: 6months
Population: Freedom from IVC Filter Related Complications was assessed by the site and reviewed by an Independent Core Lab. All subjects that had data collected were included in the analysis for population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SENTRY IVC Filter | Number of Participants With IVC Filter Related Complications | 0 participants |
| Filter Migration | Number of Participants With IVC Filter Related Complications | 0 participants |
| Filter Embolization | Number of Participants With IVC Filter Related Complications | 0 participants |
| Filter Fracture | Number of Participants With IVC Filter Related Complications | 0 participants |
| Filter Perforation | Number of Participants With IVC Filter Related Complications | 0 participants |
| Symptomatic Complications | Number of Participants With IVC Filter Related Complications | 2 participants |