The SENTRY Clinical Study

NCT01975090 | Completed Results DMC

• 1 other identifier: CI 036
• Study Type: interventional
• Target: 129
• Locations: 3 countries
• Sites: 23

Brief Summary

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

Conditions

Pulmonary Embolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With IVC Filter Related Complications

  6months

Study Arms (1)

SENTRY IVC Filter

EXPERIMENTAL

The SENTRY IVC Bioconvertible Filter

Device: SENTRY IVC Filter

Interventions

SENTRY IVC Filter DEVICE

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.

SENTRY IVC Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Novate Medical: collaborator

Study Sites (23)

Brookwood Medical Center

Birmingham, Alabama, 35243, United States

Location

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Stanford Hospital & Clinic

Palo Alto, California, 94305, United States

Location

Memorial Health System

Colorado Springs, Colorado, 80909, United States

Location

Hartford Hospital

Hartford, Connecticut, 06108, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Adventist Midwest Health

Hinsdale, Illinois, 60521, United States

Location

St. Francis Hospital

Peoria, Illinois, 61603, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Lakeview Regional Heart Center

Covington, Louisiana, 70433, United States

Location

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Rutgers-New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Imelda Hospital

Bonheiden, Belgium

Location

AZ Sint-Blasius

Dendermonde, Belgium

Location

Pontificia Universidad Catolica De Chile

Santiago, Chile

Location

Related Publications (6)

• 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.

  PMID: 12020191 BACKGROUND

• 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.

  PMID: 11265876 BACKGROUND

• 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.

  PMID: 22024114 BACKGROUND

• 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.

  PMID: 26992759 BACKGROUND

• 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.

  PMID: 30177423 BACKGROUND

• 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.

  PMID: 30112213 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Results Point of Contact

• Title: Gordon Crowley
• Organization: Novate Medical

gordon.crowley@novate.ie

+353 91 750 030

Study Officials

• Michael D Dake, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2018
• Last Updated: October 27, 2021
• Results First Posted: October 12, 2017

Record last verified: 2021-10

Locations

US (20); CL (1); BE (2)