Vena Cava Filter U.S. Clinical Trial

This study is currently recruiting participants.

Verified January 2013 by B. Braun Interventional Systems, Inc

Sponsor:

Collaborators:

BRIGHT Research Partners (formerly known as J. Abbs Inc.)

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: January 30, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

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:	323
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112917

Contacts

Contact: Andrea Fenton Abbs

(612) 298-7460

afentonabbs@comcast.net

Locations

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
Sub-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, New York
North Shore University Hospital - Manhasset	Active, not recruiting
Manhasset, New York, United States, 11030
Weill Cornell Medical College - New York Presbyterian Hospital	Active, not recruiting
New York, New York, United States, 10021
United States, Oklahoma
University of Oklahoma Health Sciences Center	Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
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	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Paul M Kiproff, MD 412-359-4113 pkiproff@wpahs.org
Sub-Investigator: Paul M Kiproff, MD
Sub-Investigator: Elmer Nahum, MD
Sub-Investigator: Jonathan MS Potts, MD
University of Pittsburgh Medical Center	Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina	Active, not recruiting
Charleston, South Carolina, United States, 29403
United States, Virginia
University of Virginia Health Systems	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ulku C Turba, MD 434-924-5775 uct5d@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: Wael Saad, MD
Sub-Investigator: Saher Sabri, MD
Sub-Investigator: Margaret C Tracci, MD
Sub-Investigator: Gilbert Upchurch, 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: Gary R Seabrook, MD
Sub-Investigator: Sarah B White, MD

Sponsors and Collaborators

B. Braun Interventional Systems, Inc

BRIGHT Research Partners (formerly known as J. Abbs Inc.)

NAMSA (formerly known as The Integra Group)

Investigators

Principal Investigator:

William S Rilling, MD

Froedtert Memorial Lutheran Hospital

More Information

Publications:

[No authors listed] Recommended reporting standards for vena caval filter placement and patient follow-up. Vena Caval Filter Consensus Conference. J Vasc Surg. 1999 Sep;30(3):573-9. Review. No abstract available.

Grassi CJ, Swan TL, Cardella JF, Meranze SG, Oglevie SB, Omary RA, Roberts AC, Sacks D, Silverstein MI, Towbin RB, Lewis CA; Society of Interventional Radiology Standards of Practice Committee. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol. 2003 Sep;14(9 Pt 2):S271-5. No abstract available.

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:	January 30, 2013
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 May 23, 2013

To Top