Trial Search Results

The SENTRY Clinical Study

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novate Medical

Stanford Investigator(s):

Intervention(s):

  • Device: SENTRY IVC Filter

Phase:

N/A

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting