A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 129
- Locations
- 43
- Primary Endpoint
- Number of Subjects That Reported Clinical Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 18 years of age
- •fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
- •willing and able to comply with follow-up visit requirements
- •requirement of transient PE protection of < 60 days
- •documented or high risk of PE or DVT
- •inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy
- •IVC diameter compatible with filter diameter
- •IVC length adequate for filter placement
Exclusion Criteria
- •intellectual impairment preventing understanding involvement in a clinical study
- •hypersensitivity to device components
- •impaired renal function defined as a serum creatinine level of > 2.0 mg/dL
- •active systemic infection
- •life expectancy < 12 months
- •malignancy extending PE risk > 60 days
- •pregnant or plans to become pregnant during study follow-up period
- •participating in another investigational trial that has not reached its primary endpoint
- •known hypercoaguable state
- •inherited or acquired hemostatic disorder
- •history or presence of a caval stent or filter
- •inability to gain femoral or jugular access
- •duplicated or left sided IVC
- •renal vein thrombosis or IVC thrombosis extending to the renal veins
- •jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery
- •spinal irregularity that may interfere with successful device delivery
- •occlusive or free-floating thrombus in the IVC
- •contrast allergy that cannot be adequately pre-medicated
Outcomes
Primary Outcomes
Number of Subjects That Reported Clinical Success
Time Frame: 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 Outcomes
- Number of Participants With IVC Filter Related Complications(6months)