Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)
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|ClinicalTrials.gov Identifier: NCT02381509|
Recruitment Status : Unknown
Verified December 2018 by HealthCore-NERI.
Recruitment status was: Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment|
|Pulmonary Embolism||Device: IVC Filter|
|Study Type :||Observational|
|Estimated Enrollment :||1800 participants|
|Official Title:||Predicting the Safety and Effectiveness of Inferior Vena Cava Filters|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2021|
IVC filter for the prevention of PE
Device: IVC Filter
- Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event [ Time Frame: within first 365 days (± 30 days) ]Clinically significant perforation is defined as protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ or that triggers the decision to remove the filter; resulting in an attempt to remove the IVC filter or requiring other intervention. Filter embolization is defined as movement of the filter or its components to a distant anatomic site completely out of the target zone after successful filter placement, confirmed by imaging. Caval thrombotic occlusion is defined as presence of an occluding thrombus in the IVC after filter insertion and documented by ultrasound (US), computed tomography (CT), magnetic resonance (MR) imaging, venography, or autopsy; this may be symptomatic or asymptomatic after successful filter placement. Deep vein thrombosis (DVT) is defined as new symptomatic DVT post-deployment, as determined by standard of care imaging. Serious adverse event is defined by ISO 14155.
- Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism [ Time Frame: at 12-months in-situ or 1-month post-retrieval (whichever comes first) ]
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): NCT02381509
|Study Chair:||David L. Gillespie, MD, RVT, FACS||Southcoast Health System|
|Study Chair:||Matt Johnson, MD||Indiana University School of Medicine|