VenaTech Convertible Vena Cava Filter U.S. Multi-Center Clinical Trial
Device: VenaTech Convertible Vena Cava Filter
Procedure: Vena Cava Filter Conversion
|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|
- 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. 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.
- Major Device-Related Adverse Events in Converted Subjects [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2011|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: VenaTech Convertible Vena Cava Filter
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
Prevention of Pulmonary EmbolismProcedure: Vena Cava Filter Conversion
Conversion of VenaTech Convertible filter to open configuration.
The investigation was designed as a multi-center, prospective, single-arm, historical (literature) controlled clinical study of VenaTech Convertible filter safety and performance in 75 subjects in whom the filter has been implanted, converted, and followed for 6-months. The study could enroll up to 323 patients to ensure 75 converted subjects with 6 months of follow-up data. Converted subjects were followed at 30-days, 3-months, and 6-months post conversion. Subjects that were unable to undergo conversion were followed at 6-months post filter implant (permanent filtration subjects).
Study subjects were to be identified from the pool of candidates with a time-limited risk for pulmonary embolism. Subjects who signed the informed consent were evaluated to determine eligibility for the study based on the inclusion and exclusion criteria. Following completion of baseline procedures including a bilateral Doppler ultrasound of the legs to assess for baseline DVT and contrast venacavography to assess baseline IVC diameter, subjects underwent implantation of the VenaTech Convertible filter.
After device implant, a clinical assessment was completed to determine eligibility for filter conversion. This assessment was done at an interval post-implant and frequency per the investigator's discretion, often with input from the primary care physician. If the clinician determined the subject was no longer at risk for pulmonary embolism, there was no thrombus in or below the filter, and there was no clinically significant deep vein thrombosis (DVT) in the legs, the filter could be converted. After conversion, subjects were followed at 30 days and 3-months by telephone, and at a 6-months post-conversion office visit with imaging (KUB or spot film and Doppler or CT).
If during the conversion clinical assessment(s), the subject remained at risk for pulmonary embolism, additional conversion assessment(s) were completed per the investigator's discretion until the filter was either converted or the subject was determined to require permanent filtration.
At 6-months post-implant, if a study subject's filter had not been converted, no further conversion assessments were to be performed and no attempts were to be made to convert the filter as part of the study. The 6-month post filter implant visit was the final follow-up for nonconverted subjects, which also included imaging (KUB or spot film and Doppler or CT). The study protocol allowed the investigators flexibility as to the best IVC imaging modality based on the condition and anatomy of the subject.
The core laboratory reviewed all screening/baseline, filter implantation, conversion eligibility assessment, conversion, and 6-month follow-up images, with the exception of the ultrasounds. (The core laboratory recommended ultrasound images be evaluated by the expert sonographers at the sites). Additionally, any images taken as a result of a suspected filter-related adverse event or technical complication, with the exception of ultrasounds, were also sent to the core laboratory for review.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112917
|United States, Florida|
|Baptist Hospital of Miami|
|Miami, Florida, United States, 33176|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Adventist Health System|
|Hinsdale, Illinois, United States, 60521|
|United States, Michigan|
|Beaumont Health System|
|Royal Oak, Michigan, United States, 48073|
|United States, New York|
|North Shore University Hospital - Manhasset|
|Manhasset, New York, United States, 11030|
|Weill Cornell Medical College - New York Presbyterian Hospital|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|United States, Virginia|
|University of Virginia Health Systems|
|Charlottesville, Virginia, United States, 22908|
|United States, Wisconsin|
|Froedtert Memorial Lutheran Hospital|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||William S Rilling, MD||Froedtert Memorial Lutheran Hospital|