Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Completed

Conditions studied: Pulmonary Embolism, Deep Vein Thrombosis

In brief

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.

Key facts

Study ID

NCT02381509

Run by

Carelon Research

People needed

1428

Starts

2015-10-01

Expected to finish

2021-09-20

Last updated by the study team

2021-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Ronald Regan UCLA Medical Center — Los Angeles, California, United States
• Palo Alto VA — Palo Alto, California, United States
• University of California San Francisco — San Francisco, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Medstar Georgetown — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• The Heart Institute Largo — Largo, Florida, United States
• University of Miami Hospital and Clinics/Jackson Memorial — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Tallahasse Memorial Hospital — Tallahassee, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Carle Heart & Vascular Institute — Urbana, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• LSU Health Sciences Center at Shreveport — Shreveport, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Southcoast Hospital — North Dartmouth, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Arkansas — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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