The SENTRY Clinical Study

Not Applicable

Completed

• Conditions: Pulmonary Embolism; Deep Vein Thrombosis

• Registration Number: NCT01975090
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Study Start: 2014-09
• Primary Completion: 2016-08
• Results First Submitted: 2017-09-14
• Results First Submitted QC: 2017-09-14
• Results First Posted: 2017-10-12
• Study Completion: 2018-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Reported Clinical Success	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 Outcome Measures

Name	Time	Method
Number of Participants With IVC Filter Related Complications	6months	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).

Trial Locations

Locations (23)

Brookwood Medical Center; 🇺🇸 Birmingham, Alabama, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Stanford Hospital & Clinic; 🇺🇸 Palo Alto, California, United States

Memorial Health System; 🇺🇸 Colorado Springs, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Adventist Midwest Health; 🇺🇸 Hinsdale, Illinois, United States

St. Francis Hospital; 🇺🇸 Peoria, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

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