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

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT01112917

Run by

B. Braun Interventional Systems, Inc

People needed

149

Starts

2011-12-01

Expected to finish

2015-09-01

Last updated by the study team

2016-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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