VenaTech Convertible Vena Cava Filter U.S. Multi-Center Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bright Research Partners
NAMSA (formerly known as The Integra Group)
Information provided by (Responsible Party):
B. Braun Interventional Systems, Inc
ClinicalTrials.gov Identifier:
NCT01112917
First received: April 8, 2010
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

The investigation is designed to verify that clinical use of the vena cava filter does not raise new questions of safety or effectiveness compared to currently-marketed permanent filters.


Condition Intervention
Pulmonary Embolism
Device: VenaTech Convertible Vena Cava Filter
Procedure: Vena Cava Filter Conversion

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: VenaTech Convertible Vena Cava Filter U.S. Multi-Center Clinical Trial

Resource links provided by NLM:


Further study details as provided by B. Braun Interventional Systems, Inc:

Primary Outcome Measures:
  • Technical success [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: December 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VenaTech Convertible Filter Device: VenaTech Convertible Vena Cava Filter
Prevention of Pulmonary Embolism
Procedure: Vena Cava Filter Conversion
Conversion of VenaTech Convertible filter to open configuration.

  Eligibility

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

Inclusion Criteria:

  • The subject is 18 years of age or older
  • The subject is at time-limited risk of pulmonary embolism
  • The subject requires prevention of pulmonary embolism and placement of a vena cava filter is indicated
  • The subject is willing and able to provide informed consent
  • The subject is willing and able to comply with the requirements of the study protocol
  • The subject's vena cava diameter is less than or equal to 28mm.

Exclusion Criteria:

  • The subject is pregnant, planning on becoming pregnant or unwilling to use birth control
  • The subject is severely disabled and his/her life expectancy appears limited
  • The subject already has an implanted vena cava filter
  • The subject has contrast allergy
  • The subject has a duplicated IVC
  • The subject is bacteremic
  • The subject has an active malignancy with associated hypercoagulability or mortality
  • The subject would be unavailable for follow-up
  • Filter implantation is not possible
  • There is no location available for placement of the vena cava filter
  • The subject is currently participating in another clinical study or has participated in one within the last 30 days or plans to participate in one during the next 6 months
  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: NCT01112917

Locations
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Adventist Health System
Hinsdale, Illinois, United States, 60521
United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
United States, New York
North Shore University Hospital - Manhasset
Manhasset, New York, United States, 11030
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Virginia
University of Virginia Health Systems
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
B. Braun Interventional Systems, Inc
Bright Research Partners
NAMSA (formerly known as The Integra Group)
Investigators
Principal Investigator: William S Rilling, MD Froedtert Memorial Lutheran Hospital
  More Information

Publications:
Responsible Party: B. Braun Interventional Systems, Inc
ClinicalTrials.gov Identifier: NCT01112917     History of Changes
Other Study ID Numbers: CL-104
Study First Received: April 8, 2010
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014