The SENTRY Clinical Study

Trial ID or NCT#

NCT01975090

Status

recruiting iconRECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

David S. Wang, MD
Interventional radiologist, Radiologist, Minimally invasive surgeon, Diagnostic radiologist
Clinical Associate Professor, Radiology

View on ClinicalTrials.gov