Predicting the Safety and Effectiveness of Inferior Vena Cava Filters



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:October 2015
End Date:May 2020
Contact:Olivia Wheaton, BA
Email:owheaton@neriscience.com
Phone:617-972-3082

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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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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Urbana, Illinois 61801
Principal Investigator: Jeremy Hogg
Phone: 217-383-6622
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Suvranu Ganguli
Phone: 617-643-0244
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Mark Lessne, MD
Phone: 704-266-0092
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Karunakaravel Karuppasamy Karuppasamy, MD
Phone: 216-444-0617
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Alain Drooz
Phone: 703-776-7874
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Thomas Casciani, MD
Phone: 317-962-5201
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Little Rock, Arkansas 72202
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Michael Rosenberg, MD
Phone: 612-624-4865
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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Phone: 215-662-4320
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1000 W Carson St
Torrance, California 90502
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Albany, New York 12208
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Boston, Massachusetts 02118
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Robert Lewandowski, MD
Phone: 312-695-4023
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Dallas, Texas 75390
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Dayton, Ohio 45409
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Durham, North Carolina 27708
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Houston, Texas 77030
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
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Los Angeles, California 90095
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Manhasset, New York 11030
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8701 West Watertown Plank Road
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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New York, New York 10065
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Phone: 212-746-9748
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New York, New York 10029
Principal Investigator: Robert Lookstein, MD
Phone: 212-241-2317
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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North Dartmouth, Massachusetts 02747
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
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Florida Hospital Florida Hospital is one of the country
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Palo Alto, California 94304
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97239
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Providence, Rhode Island 02903
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Rochester, Minnesota 55905
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Rochester, New York 14621
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63110
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San Diego, California 92093
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San Francisco, California 94143
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
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Shreveport, Louisiana 71130
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
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Washington, District of Columbia 20007
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