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Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

NCT02381509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1428

Last updated 2021-10-04

No results posted yet for this study

Summary

PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.

Conditions

Interventions

DEVICE

IVC Filter

Sponsors & Collaborators

  • ALN Implants Chirurgicaux

    collaborator UNKNOWN

  • B. Braun Interventional Systems, Inc

    collaborator INDUSTRY

  • Bard Peripheral Vascular, Inc.

    collaborator INDUSTRY

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Cordis Corporation

    collaborator INDUSTRY

  • Argon Medical Devices

    collaborator INDUSTRY

  • Society of Interventional Radiology Foundation

    collaborator OTHER

  • Society for Vascular Surgery

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • David L. Gillespie, MD, FACS · Cape Cod Hospital

  • Matt Johnson, MD · Indiana University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-03-17
Completion
2021-09-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381509 on ClinicalTrials.gov