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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by B. Braun Interventional Systems, Inc
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: February 27, 2014
Last verified: February 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: December 2014
Estimated Primary Completion Date: April 2014 (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

Contacts
Contact: Andrea Fenton Abbs (612) 298-7460 andrea@brightresearchpartners.com

Locations
United States, Florida
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Shaun Samuels, MD    786-596-5990    ShaunS@baptisthealth.net   
Principal Investigator: Shaun LW Samuels, MD         
Sub-Investigator: James F Benenati, MD         
Sub-Investigator: Ripal T Gandhi, MD         
Sub-Investigator: Barry T Katzen, MD         
Sub-Investigator: Constantino S Pena, MD         
Sub-Investigator: Alex Powell, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Lewandowski, MD    312-695-9121    r-lewandowski@northwestern.edu   
Principal Investigator: Robert Lewandowski, MD         
Sub-Investigator: Albert Nemcek, MD         
Sub-Investigator: Scott Resnick, MD         
Sub-Investigator: Robert K Ryu, MD         
Sub-Investigator: Robert Vogelzang, MD         
Adventist Health System Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Steven Smith, MD    630-856-7460    smithmd2@comcast.net   
Principal Investigator: Steven Smith, MD         
Principal Investigator: Athanasios (Tom) Vlahos, MD         
Sub-Investigator: Frank (Francis) Facchini, MD         
Sub-Investigator: Michael Sichlau, MD         
Sub-Investigator: Luke Sewall, MD         
Sub-Investigator: Ketan Amin, MD         
Sub-Investigator: George Behrens, MD         
United States, Michigan
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Jeremy Handel, MD    248-898-7456    jeremy.handel@beaumont.edu   
Principal Investigator: Jeremy Handel, MD         
Sub-Investigator: Joseph A Ciacci, MD         
Sub-Investigator: Purushottam Dixit, MD         
Sub-Investigator: Matthias J Kirsch, MD         
Sub-Investigator: Michael A Savin, MD         
Sub-Investigator: Andrew Vartanian, MD         
United States, New York
North Shore University Hospital - Manhasset Terminated
Manhasset, New York, United States, 11030
Weill Cornell Medical College - New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: David W Trost, MD    212-746-2603    datrost@med.cornell.edu   
Principal Investigator: David W Trost, MD         
Principal Investigator: David C Madoff, MD         
Sub-Investigator: Bradley B Pua, MD         
Sub-Investigator: Marc Schiffman, MD         
Sub-Investigator: Adam D Talenfeld, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Paul O'Moore, MD    215-481-2071    pomoore@amh.org   
Principal Investigator: Paul O'Moore, MD         
Sub-Investigator: S. Yedida Goldman, MD         
Sub-Investigator: Hans Y Kim, MD         
Sub-Investigator: Alexander M Nemeth, MD         
Sub-Investigator: Naishadh Shah, MD         
Sub-Investigator: Steven Tey, MD         
Allegheny General Hospital Terminated
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: J. Bayne Selby, Jr., MD    843-792-1930    selbyjr@musc.edu   
Principal Investigator: J. Bayne Selby, Jr., MD         
Sub-Investigator: Michael B Anderson, MD         
Sub-Investigator: Marcelo Guimaraes, MD         
Sub-Investigator: Christopher Hannegan, MD         
Sub-Investigator: Claudio J Schonholz, MD         
Sub-Investigator: Ricardo Yamada, MD         
United States, Virginia
University of Virginia Health Systems Recruiting
Charlottesville, Virginia, United States, 22908
Contact: James C Stone, MD    434-924-9401    Jrs7r@virginia.edu   
Principal Investigator: James Stone, MD, PhD         
Sub-Investigator: Alan H Matsumoto, MD         
Sub-Investigator: John Angle, MD         
Sub-Investigator: Kenneth Cherry, MD         
Sub-Investigator: John Kern, MD         
Sub-Investigator: Auh W Park, MD         
Sub-Investigator: Saher Sabri, MD         
Sub-Investigator: Margaret C Tracci, MD         
United States, Wisconsin
Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William S Rilling, MD    414-805-3125    wrilling@mcw.edu   
Principal Investigator: William S Rilling, MD         
Sub-Investigator: Eric J Hohenwalter, MD         
Sub-Investigator: Robert A Hieb, MD         
Sub-Investigator: Sean M Tutton, MD         
Sub-Investigator: Parag J Patel, MD         
Sub-Investigator: James B Gosset, MD         
Sub-Investigator: Kellie R Brown, MD         
Sub-Investigator: Brian D Lewis, MD         
Sub-Investigator: Peter Rossi, MD         
Sub-Investigator: Sarah B White, MD         
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: February 27, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014