Pulmonary EmbolismSENTRYNCT01975090
The SENTRY Clinical Study
A study testing SENTRY IVC Filter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Boston Scientific Corporation at 23 sites in 3 countries.
Trial summary
The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- SENTRY IVC Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Sep 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States20 sites
Emory University
Atlanta, Georgia, 30322
Brookwood Medical Center
Birmingham, Alabama, 35243
University of Alabama
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 27599
Memorial Health System
Colorado Springs, Colorado, 80909
Riverside Methodist Hospital
Columbus, Ohio, 43214
Lakeview Regional Heart Center
Covington, Louisiana, 70433
University of Texas Southwestern
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06108
Adventist Midwest Health
Hinsdale, Illinois, 60521
Indiana University
Indianapolis, Indiana, 46202
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103
Stanford Hospital & Clinic
Palo Alto, California, 94305
St. Francis Hospital
Peoria, Illinois, 61603
Rhode Island Hospital
Providence, Rhode Island, 02903
Rex Hospital
Raleigh, North Carolina, 27607
Providence Medical Research Center
Spokane, Washington, 99204
Washington University in St Louis
St Louis, Missouri, 63110
Jobst Vascular Institute
Toledo, Ohio, 43606
About this study
Official title: A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).
Read the 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.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- SENTRY IVC Filter
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENTRY IVC FilterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SENTRY IVC Filter | Experimental | The SENTRY IVC Bioconvertible Filter Receives: Device: SENTRY IVC Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Secondary outcomes (1)
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).
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novate Medical
- Responsible party
- Sponsor
- Investigators
- Michael D Dake, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975090
- Sponsor's protocol ID
- CI 036
- Acronym
- SENTRY
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2013
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
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.
PubMed 12020191Grassi 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.
PubMed 11265876Angel 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.
PubMed 22024114Morales 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.
PubMed 26992759Dake 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.
PubMed 30177423Gaines 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.
PubMed 30112213
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
- ClinicalTrials.gov ID
- NCT01975090
- Acronym / sponsor ID
- SENTRY / CI 036
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Novate Medical
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 12 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENTRY IVC Filter | Experimental | Device: SENTRY IVC FilterThe SENTRY IVC Bioconvertible Filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENTRY IVC FilterThe 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. | Device | SENTRY IVC Filter |
Primary outcome
Number of Subjects That Reported Clinical Success
Time frame: 6 Months
A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
1 secondary outcome
Number of Participants With IVC Filter Related Complications
Time frame: 6months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12020191Tsai 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.
- Background: PubMed 11265876Grassi 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.
- Background: PubMed 22024114Angel 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.
- Background: PubMed 26992759Morales 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.
- Background: PubMed 30177423Dake 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.
- Background: PubMed 30112213Gaines 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Dake, MD principal investigator
Stanford University
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENTRY IVC Filter in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Boston Scientific Corporation at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Belgium, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Reported Clinical Success (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975090, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.