The SENTRY Clinical Study
- Conditions
- Pulmonary EmbolismDeep 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- > 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
- 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
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).
Related Research Topics
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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
Scroll for more (13 remaining)Brookwood Medical Center🇺🇸Birmingham, Alabama, United States