Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Trial
The PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) Trial is the first large-scale, multi-specialty, prospective clinical study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment in the United States. With the guidance of the Food and Drug Administration (FDA), the study will help determine how well filters prevent pulmonary embolisms and when retrievable filters should be removed, thus advancing patient safety.
The trial is sponsored by the IVC Filter Study Group Foundation, a joint collaboration between the Society of Interventional Radiology and the Society for Vascular Surgery.
For additional information, please visit ClinicalTrials.gov.
PRESERVE Publication highlights its unique design and collaborative support
In October 2019, the PRESERVE Steering Committee published a methodology paper in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. The article focuses on the unique structure of the study and the combined support of various stakeholders, including the Society of Interventional Radiology, the Society for Vascular Surgery, U.S. Food and Drug Administration and several IVC filter manufacturers. Subject enrollment is closed, and the study is in the process of completing follow-up visits and data cleaning.
PRESERVE has transitioned into a new phase
PRESERVE enrollment officially closed on March 31, 2019, with a total of 1,430 subjects by 54 sites. All subjects will continue to be followed for up to 2 years after enrollment. A total of 7 filter manufacturers participated in the trial.
PRESERVE has shifted its focus to subject retention in order to ensure adequate power for statistical analyses. Lead investigators, site coordinators, and research staff are encouraged to maintain communication with subjects and to collect follow-up data.
Continued participation and follow-up data are integral to the success of PRESERVE.
If you have any questions about PRESERVE, please contact the Director of Clinical Research and Grants.
Listen to Matthew Johnson, MD, FSIR, the co-chair of the PRESERVE Steering Committee, discuss the background and current status of this important initiative.