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

NCT01112917 | Completed Results DMC

• 1 other identifier: CL-104
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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. Further, in the analysis of the data, the sponsor did not count any filters as a 'technically' successful conversion when the operator was unable to snare the filter hook during an attempted conversion.

  6-months

Secondary Outcomes (1)

• Major Device-Related Adverse Events in Converted Subjects

  6-months

Study Arms (1)

VenaTech Convertible Vena Cava Filter

EXPERIMENTAL

Implantation of the VenaTech Convertible Filter. The filter is pre-loaded in a cartridge (syringe) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either using the femoral or jugular approach.

Device: VenaTech Convertible Vena Cava Filter; Procedure: Vena Cava Filter Conversion

Interventions

VenaTech Convertible Vena Cava Filter DEVICE

Prevention of Pulmonary Embolism

VenaTech Convertible Vena Cava Filter

Vena Cava Filter Conversion PROCEDURE

Conversion of VenaTech Convertible filter to open configuration.

VenaTech Convertible Vena Cava Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18 years of age or older
• The subject is at a time-limited risk of pulmonary embolism as judged by the implanting or referring physician
• In the physician's judgment, the subject requires prevention of pulmonary embolism and placement of a vena cava filter is indicated because anticoagulants are contraindicated, or the subject has experienced failure of anticoagulant therapy in thromboembolic diseases in the past, or the subject requires emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced
• The subject, or their legal representative, is willing and able to provide informed consent
• The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up visit evaluations
• The subject's vena cava diameter is ≤ 28 mm as evaluated by contrast venacavography and corrected for magnification

You may not qualify if:

• The subject is a female of childbearing potential and known to be, or suspected to be, pregnant (verified with a urine/blood pregnancy test), or unwilling to use an acceptable form of birth control for as long as the device is implanted
• The subject is severely disabled and his/her life expectancy appears limited according to the investigator's opinion (≤ 6 months)
• The subject already has an implanted vena cava filter
• The subject has contrast allergy to both iodinated contrast and non-iodinated contrast materials
• The subject has a duplicated IVC
• The subject is bacteremic
• The subject has an active malignancy with associated hypercoagulability or mortality likely preventing the VenaTech Convertible filter from being converted within 6 months of implant
• The subject would be unavailable for follow-up
• Filter implantation using the right internal jugular or femoral veins is not possible
• There is no location available in the infrarenal inferior vena cava for placement of the VenaTech Convertible vena cava filter (assessed using contrast venacavography)
• 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

Sponsors & Collaborators

• B. Braun Interventional Systems, Inc: lead
• Bright Research Partners: collaborator
• NAMSA: collaborator

Study Sites (11)

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Adventist Health System

Hinsdale, Illinois, 60521, United States

Location

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

North Shore University Hospital - Manhasset

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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. No abstract available.

  PMID: 10477662 BACKGROUND

• 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.

  PMID: 14514832 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Andrea Fenton Abbs - Study Director
• Organization: BRIGHT Research Partners

andrea@brightresearchpartners.com

612-298-7460

Study Officials

• William S Rilling, MD

  Froedtert Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 29, 2010
• Study Start: December 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)