The SENTRY Clinical Study

Boston Scientific

Status: Completed

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Device: SENTRY IVC Filter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975090

CI 036

Details and patient eligibility

About

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

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

SENTRY IVC Filter

Experimental group

Description:

The SENTRY IVC Bioconvertible Filter

Treatment:

Device: SENTRY IVC Filter