The SENTRY Clinical Study

N/ACompletedNCT01975090

Boston Scientific Corporation129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

129

Conditions

Pulmonary Embolism Deep Vein Thrombosis

Interventions

SENTRY IVC FilterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Brookwood Medical Center

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.