As the clinical trial landscape evolves and the interest in real-world evidence (RWE) continues to grow, the U.S. Food and Drug Administration (FDA) recently issued guidance on the use of RWE to support regulatory decision-making for medical devices (August 2017). This represents a major paradigm shift from the traditional methods of designing trials and collecting data.
To this end, the Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Trial represents the largest multispecialty, prospective, pragmatic clinical research trial to date to evaluate the real-world safety and effectiveness of inferior vena cava (IVC) filters. This landmark trial will provide an invaluable dataset of 1,800 patients with IVC filters that can be used to better inform the best utilization for IVC filters and to maximize the benefit to patients while minimizing risk. The trial has met over half of its enrollment goal with 1,083 subjects among 49 active sites.
The trial is sponsored by the IVC Filter Study Group Foundation, a nonprofit research arm of the joint efforts of SIR and the Society for Vascular Surgery (SVS). The PRESERVE Trial is being led by Co-principal Investigators Matthew S. Johnson, MD, FSIR, professor of radiology research, radiology and surgery at Indiana University School of Medicine in Indianapolis, and David L. Gillespie, MD, chief of vascular and endovascular surgery at Southcoast Health System in Fall River, Massachusetts. The following manufacturers and filters are participating in the PRESERVE Trial:
- ALN—ALN with/without hook
- Argon—Option ELITE
- B. Braun—VenaTech LP and VenaTech Convertible
- Cook—Günther Tulip
- Cordis—OPTEASE and TRAPEASE
- C.R. Bard—Denali
The protocol was specifically designed to assess the mechanical stability of IVC filters as well as other measures of safety, while utilizing traditional medical device trial methods of utilizing a core imaging laboratory to centrally read pre- and postplacement venogram, imaging endpoints, short-term X-rays and long-term CT scans of the filters if still in place.
The trial is encouraging all participating investigators to continue their enrollment efforts. The PRESERVE Trial is seeking additional U.S. sites that insert the VenaTech and OPTEASE/TRAPEASE filters.
For more information about the trial, please visit the website at preservetrial.com or contact preserve@neriscience.com.
