The SENTRY Clinical Study (SENTRY)
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|ClinicalTrials.gov Identifier: NCT01975090|
Recruitment Status : Completed
First Posted : November 3, 2013
Results First Posted : October 12, 2017
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Deep Vein Thrombosis||Device: SENTRY IVC Filter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||December 2018|
Experimental: SENTRY IVC Filter
The SENTRY IVC Bioconvertible 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.
- Number of Subjects That Reported Clinical Success [ Time Frame: 6 Months ]
A Composite Endpoint including:
Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
- Number of Participants With IVC Filter Related Complications [ Time Frame: 6months ]IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975090
|Principal Investigator:||Michael D Dake, MD||Stanford University|