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The SENTRY Clinical Study (SENTRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01975090
Recruitment Status : Active, not recruiting
First Posted : November 4, 2013
Results First Posted : October 12, 2017
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Pulmonary Embolism Deep Vein Thrombosis Device: SENTRY IVC Filter

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
Study Start Date : September 2014
Primary Completion Date : August 2016
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter
Device: SENTRY IVC Filter
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.

Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects That Reported Clinical Success [ Time Frame: 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 :
  1. IVC Filter Related Complications [ Time Frame: 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975090

  Hide Study Locations
United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35243
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Stanford Hospital & Clinic
Palo Alto, California, United States, 94305
United States, Colorado
Memorial Health System
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06108
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Adventist Midwest Health
Hinsdale, Illinois, United States, 60521
St. Francis Hospital
Peoria, Illinois, United States, 61603
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Lakeview Regional Heart Center
Covington, Louisiana, United States, 70433
United States, Missouri
Washington University in St Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Rutgers-New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Jobst Vascular Institute
Toledo, Ohio, United States, 43606
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Imelda Hospital
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
Pontificia Universidad Catolica De Chile
Santiago, Chile
Sponsors and Collaborators
Novate Medical
Principal Investigator: Michael D Dake, MD Stanford University
More Information

Responsible Party: Novate Medical
ClinicalTrials.gov Identifier: NCT01975090     History of Changes
Other Study ID Numbers: CI 036
First Posted: November 4, 2013    Key Record Dates
Results First Posted: October 12, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases