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