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The SENTRY Clinical Study
Recruiting
Trial ID: NCT01975090
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
Stanford Investigator(s)
David S. Wang, MD
Clinical Associate Professor, Radiology
Eligibility
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
Intervention(s):
device: SENTRY IVC Filter
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305