Clinical trial NCT01975090: The SENTRY Clinical Study
Official title: A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Novate Medical
First posted: 2013-11-03
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects That Reported Clinical Success
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants With IVC Filter Related Complications
timeFrame: 6months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Stanford Hospital & Clinic
state: California
city: Colorado Springs
country: United States
facility: Memorial Health System
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Hinsdale
country: United States
facility: Adventist Midwest Health
state: Illinois
city: Peoria
country: United States
facility: St. Francis Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Covington
country: United States
facility: Lakeview Regional Heart Center
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Newark
country: United States
facility: Rutgers-New Jersey Medical School
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica De Chile
Study officials:
affiliation: Stanford University
name: Michael D Dake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.