The SENTRY Clinical Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Novate Medical
Sponsor:
Information provided by (Responsible Party):
Novate Medical
ClinicalTrials.gov Identifier:
NCT01975090
First received: October 28, 2013
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Pulmonary Embolism
Deep Vein Thrombosis
Device: SENTRY IVC Filter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cave Filter

Resource links provided by NLM:


Further study details as provided by Novate Medical:

Primary Outcome Measures:
  • Clinical Success Rate of the Sentry IVC Filter [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

    A Composite Endpoint including:

    Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications



Secondary Outcome Measures:
  • (1) Technical Success (2) Filter Status (3) Symptomatic PE (4) Freedom from IVC filter related complications [ Time Frame: 1, 2, 6 and 12 Months ] [ Designated as safety issue: Yes ]
    IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, symptomatic caval thrombosis, invasive filter intervention and filter-related death.


Other Outcome Measures:
  • (1) New Symptomatic DVT(5) Procedure related serious adverse events (SAE) (2) New or symptomatic venous thromboembolism [ Time Frame: 1, 2, 6 and 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 135
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENTRY IVC Filter
The SENTRY IVC Bioconveretible Filter
Device: SENTRY IVC Filter
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975090

Contacts
Contact: Dennis P. McHugh, MS +1-925-558-2642 dennis.mchugh@novate.biz

  Show 23 Study Locations
Sponsors and Collaborators
Novate Medical
Investigators
Principal Investigator: Michael D Dake, MD Stanford University
  More Information

Publications:
Responsible Party: Novate Medical
ClinicalTrials.gov Identifier: NCT01975090     History of Changes
Other Study ID Numbers: CI 036
Study First Received: October 28, 2013
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration
Chile: Institutional Review Board
Belgium: Agence fédérale des médicaments et des produits de santé

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014