The SENTRY Clinical Study
The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cave Filter|
- Clinical Success Rate of the Sentry IVC Filter [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
A Composite Endpoint including:
Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
- (1) Technical Success (2) Filter Status (3) Symptomatic PE (4) Freedom from IVC filter related complications [ Time Frame: 1, 2, 6 and 12 Months ] [ Designated as safety issue: Yes ]IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, symptomatic caval thrombosis, invasive filter intervention and filter-related death.
- (1) New Symptomatic DVT(5) Procedure related serious adverse events (SAE) (2) New or symptomatic venous thromboembolism [ Time Frame: 1, 2, 6 and 12 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: SENTRY IVC Filter
The SENTRY IVC Bioconveretible Filter
Device: SENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.
Pulmonary embolism (PE) is a prevalent disease with a significant morbidity and mortality. The estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the United States. It is estimated that PE results in more than 200,000 deaths per year.
Currently there are two types of commercially available IVC filters utilized to prevent PE; permanent and retrievable. Both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (DVT). Retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. In a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%.
There are numerous design features of the SENTRY IVC Filter that are intended to improve on the limitations of available IVC filters and obviate the need for retrieval.