Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2014-09-30
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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SENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Novate Medical
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael D Dake, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Lakeview Regional Heart Center
Covington, Louisiana, United States
Washington University in St Louis
St Louis, Missouri, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Rex Hospital
Raleigh, North Carolina, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas Southwestern
Dallas, Texas, United States
Providence Medical Research Center
Spokane, Washington, United States
Imelda Hospital
Bonheiden, , Belgium
AZ Sint-Blasius
Dendermonde, , Belgium
Pontificia Universidad Catolica De Chile
Santiago, , Chile
Countries
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References
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Tsai AW, Cushman M, Rosamond WD, Heckbert SR, Polak JF, Folsom AR. Cardiovascular risk factors and venous thromboembolism incidence: the longitudinal investigation of thromboembolism etiology. Arch Intern Med. 2002 May 27;162(10):1182-9. doi: 10.1001/archinte.162.10.1182.
Grassi CJ, Swan TL, Cardella JF, Meranze SG, Oglevie SB, Omary RA, Roberts AC, Sacks D, Silverstein MI, Towbin RB, Lewis CA; Society of Cardiovascular & Interventional Radiology, Standards of Practice Committee. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. SCVIR Standards of Practice Committee. J Vasc Interv Radiol. 2001 Feb;12(2):137-41. doi: 10.1016/s1051-0443(07)61818-1. No abstract available.
Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011 Nov;22(11):1522-1530.e3. doi: 10.1016/j.jvir.2011.08.024.
Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M, Cavanaugh KJ Jr. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2013 Oct;1(4):376-84. doi: 10.1016/j.jvsv.2013.04.005. Epub 2013 Jul 4.
Dake MD, Murphy TP, Kramer AH, Darcy MD, Sewall LE, Curi MA, Johnson MS, Arena F, Swischuk JL, Ansel GM, Silver MJ, Saddekni S, Brower JS, Mendes R; SENTRY Trial Investigators. One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter. J Vasc Interv Radiol. 2018 Oct;29(10):1350-1361.e4. doi: 10.1016/j.jvir.2018.05.009. Epub 2018 Sep 1.
Gaines PA, Kolodgie FD, Crowley G, Horan S, MacDonagh M, McLucas E, Rosenthal D, Strong A, Sweet M, Panchal DK. Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model. Int J Vasc Med. 2018 Jul 19;2018:6981505. doi: 10.1155/2018/6981505. eCollection 2018.
Other Identifiers
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CI 036
Identifier Type: -
Identifier Source: org_study_id