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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112917
• Other study ID #: CL-104
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: January 11, 2016
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: B. Braun Interventional Systems, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Embolism

Intervention

Device:
• VenaTech Convertible Vena Cava Filter
Prevention of Pulmonary Embolism

Procedure:
• Vena Cava Filter Conversion
Conversion of VenaTech Convertible filter to open configuration.

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Adventist Health System	Hinsdale	Illinois
United States	North Shore University Hospital - Manhasset	Manhasset	New York
United States	Baptist Hospital of Miami	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Beaumont Health System	Royal Oak	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
B. Braun Interventional Systems, Inc	Bright Research Partners, NAMSA

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Vena Caval Filter Consensus Conference. Recommended reporting standards for vena caval filter placement and patient follow-up. J Vasc Surg. 1999 Sep;30(3):573-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs.	6-months	No
Secondary	Adverse Events		6-months	Yes