The SENTRY Clinical Study

Pulmonary Embolism Clinical Trial

— SENTRY  

Official title:

A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975090
• Other study ID #: CI 036
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: October 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Chile	Pontificia Universidad Catolica De Chile	Santiago
United States	Emory University	Atlanta	Georgia
United States	Brookwood Medical Center	Birmingham	Alabama
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Memorial Health System	Colorado Springs	Colorado
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Lakeview Regional Heart Center	Covington	Louisiana
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Adventist Midwest Health	Hinsdale	Illinois
United States	Indiana University	Indianapolis	Indiana
United States	Rutgers-New Jersey Medical School	Newark	New Jersey
United States	Stanford Hospital & Clinic	Palo Alto	California
United States	St. Francis Hospital	Peoria	Illinois
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Rex Hospital	Raleigh	North Carolina
United States	Washington University in St Louis	Saint Louis	Missouri
United States	Providence Medical Research Center	Spokane	Washington
United States	Jobst Vascular Institute	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Novate Medical

Countries where clinical trial is conducted

United States,  Belgium,  Chile, 

References & Publications (6)

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. Review. — View Citation

Dake MD, Murphy TP, Krämer 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects That Reported Clinical Success	A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications	6 Months
Secondary	Number of Participants With IVC Filter Related Complications	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).	6months