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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Pallav Kolli

Description

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 approximately 1,800 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. 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.

Keywords

Pulmonary Embolism inferior vena cava filters

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or Female, age 18 years or older;
  • Requires IVC filter for prevention of pulmonary embolism (PE);
  • Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
  • Willing to comply with the specified follow-up

You CAN'T join if...

  • Subject is unable to participate in study evaluations pre- and post-treatment
  • Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms

Locations

  • Palo Alto VA accepting new patients
    Palo Alto, California, 94304, United States
  • Ronald Regan UCLA Medical Center accepting new patients
    Los Angles, California, 90024, United States
  • Harbor-UCLA Medical Center accepting new patients
    Torrance, California, 90502, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New England Research Institutes
ID
NCT02381509
Lead Scientist
Pallav Kolli
Study Type
Observational
Last Updated
October 2015
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