The SENTRY Clinical Study

Study Overview
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Brief Summary
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The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter

Conditions
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Pulmonary Embolism, Deep Vein Thrombosis

Intervention / Treatment
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* Device: SENTRY IVC Filter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SENTRY IVC Filter<br>The SENTRY IVC Bioconvertible Filter | Device: SENTRY IVC Filter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6months |