The SENTRY Clinical Study

Completed · Not applicable

Conditions studied: Pulmonary Embolism, Deep Vein Thrombosis

In brief

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

Key facts

Study ID

NCT01975090

Run by

Boston Scientific Corporation

People needed

129

Starts

2014-09-01

Expected to finish

2018-12-01

Last updated by the study team

2021-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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