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The SENTRY Clinical Study (SENTRY)

Primary Purpose

Pulmonary Embolism, Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SENTRY IVC Filter
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brookwood Medical Center
  • University of Alabama
  • Stanford Hospital & Clinic
  • Memorial Health System
  • Hartford Hospital
  • University of Florida
  • Emory University
  • Adventist Midwest Health
  • St. Francis Hospital
  • Indiana University
  • Lakeview Regional Heart Center
  • Washington University in St Louis
  • Rutgers-New Jersey Medical School
  • University of North Carolina
  • Rex Hospital
  • Riverside Methodist Hospital
  • Jobst Vascular Institute
  • Rhode Island Hospital
  • University of Texas Southwestern
  • Providence Medical Research Center
  • Imelda Hospital
  • AZ Sint-Blasius
  • Pontificia Universidad Catolica De Chile

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENTRY IVC Filter

Arm Description

The SENTRY IVC Bioconvertible Filter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
October 28, 2013
Last Updated
October 25, 2021
Sponsor
Boston Scientific Corporation
Collaborators
Novate Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01975090
Brief Title
The SENTRY Clinical Study
Acronym
SENTRY
Official Title
A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Novate Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENTRY IVC Filter
Arm Type
Experimental
Arm Description
The SENTRY IVC Bioconvertible Filter
Intervention Type
Device
Intervention Name(s)
SENTRY IVC Filter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects That Reported Clinical Success
Description
A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Participants With IVC Filter Related Complications
Description
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).
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 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 Exclusion Criteria: 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 spinal irregularity that may interfere with successful device delivery occlusive or free-floating thrombus in the IVC contrast allergy that cannot be adequately pre-medicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Dake, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford Hospital & Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Memorial Health System
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06108
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Adventist Midwest Health
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
St. Francis Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lakeview Regional Heart Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers-New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Facility Name
AZ Sint-Blasius
City
Dendermonde
Country
Belgium
Facility Name
Pontificia Universidad Catolica De Chile
City
Santiago
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
12020191
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.
Results Reference
background
PubMed Identifier
11265876
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.
Results Reference
background
PubMed Identifier
22024114
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.
Results Reference
background
PubMed Identifier
26992759
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.
Results Reference
background
PubMed Identifier
30177423
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.
Results Reference
background
PubMed Identifier
30112213
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.
Results Reference
background

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The SENTRY Clinical Study

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