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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Trial Summary
Trial Overview
Inclusion Criteria
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
54
sites
University of California at San Francisco
San Francisco, California 94143
Principal Investigator: Pallav Kolli, MD
Phone: 415-353-2310
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Suvranu Ganguli
Phone: 617-643-0244
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Carolinas Medical Center
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Mark Lessne, MD
Phone: 704-266-0092
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Charlotte, NC
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Cleveland Clinic
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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Inova Fairfax Hospital
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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Holy Cross Hospital
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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Indiana University
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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University of Arkansas
Little Rock, Arkansas 72202
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Michael Rosenberg, MD
Phone: 612-624-4865
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Benjamin Jackson, MD
Phone: 215-662-4320
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Harbor UCLA Medical Center
1000 W Carson St
Torrance, California 90502
Principal Investigator: Rodney A White, MD
Phone: 310-222-5249
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Albany Medical Center
Albany, New York 12208
Principal Investigator: Gary Siskin, MD
Phone: 518-262-5356
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Minjajuddin Khaja, MD
Phone: 734-936-8556
University of Michigan The University of Michigan was founded in 1817 as one of the...
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University of Colorado
Aurora, Colorado 80045
Principal Investigator: Paul Rochon, MD
Phone: 720-848-6137
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Boston Med Ctr
Boston, Massachusetts 02118
Principal Investigator: Jeffrey Kalish, MD
Phone: 617-414-6832
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Northwestern Memorial Hospital
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Robert Lewandowski, MD
Phone: 312-695-4023
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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UT Southwestern
Dallas, Texas 75390
Principal Investigator: Sanjeeva Kalva, MD
Phone: 214-648-5474
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Miami Valley Hospital/Wright State University
Dayton, Ohio 45409
Principal Investigator: Shannon Kauffman, MD
Phone: 937-208-6013
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Duke Medical Center
Durham, North Carolina 27708
Principal Investigator: David Sopko, MD
Phone: 919-684-7277
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Hackensack UMC
Hackensack, New Jersey 07601
Principal Investigator: Gregory Simonian, MD
Phone: 551-996-5722
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Memorial Hermann Hospital
Houston, Texas 77030
Principal Investigator: Alan Cohen, MD
Phone: 713-500-7073
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Fairfield Medical Center
401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Principal Investigator: Krishna Mannava, MD
Phone: 740-689-4426
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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The Heart Institute at Largo
Largo, Florida 33770
Principal Investigator: Merrill Krolick, MD
Phone: 727-489-5416
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Ronald Regan UCLA Medical Center
Los Angeles, California 90095
Principal Investigator: John Moriarty, MD
Phone: 310-794-8334
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Feinstein Institute
Manhasset, New York 11030
Principal Investigator: Eric Gandras, MD
Phone: 516-881-7022
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University of Miami Hospital and Clinics/Jackson Memorial
Miami, Florida 33136
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Medical College of WI/Froedtert Memorial Lutheran Hospital
8701 West Watertown Plank Road
Milwaukee, Wisconsin 53226
Principal Investigator: Eric Hohenwalter, MD
Phone: 414-805-2077
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Yale-New Haven Hospital
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Cassius Chaar, MD
Phone: 203-737-1899
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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NY Presbyterian Weil Cornell Medical Ctr
New York, New York 10065
Principal Investigator: David Trost, MD
Phone: 212-746-9748
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Mount Sinai Hosp
New York, New York 10029
Principal Investigator: Robert Lookstein, MD
Phone: 212-241-2317
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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Robert Siegelbaum, MD
Phone: 646-888-1356
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Southcoast Hospital
North Dartmouth, Massachusetts 02747
Principal Investigator: Michael Ayad, MD
Phone: 281-827-1985
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Florida Hospital
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Ronald Schill, MD
Phone: 407-303-7510
Florida Hospital Florida Hospital is one of the country
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Palo Alto VA
Palo Alto, California 94304
Principal Investigator: George Lee, MD
Phone: 650-849-0357
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University of Pittsburgh Medical Center
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Eric Hager, MD
Phone: 412-235-1303
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Oregon Health and Science Center
Portland, Oregon 97239
Principal Investigator: John Kaufman, MD
Phone: 503-494-7226
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Rhode Island Hospital and The Miriam Hospital
Providence, Rhode Island 02903
Principal Investigator: Timothy P Murphy, MD
Phone: 401-444-1739
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The Mayo Clinic
Rochester, Minnesota 55905
Principal Investigator: Haraldur Bjarnason, MD
Phone: 507-538-0540
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Rochester Regional Health System
Rochester, New York 14621
Principal Investigator: Donnette Dabydeen
Phone: 585-747-2713
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William Beaumont Hospital
Royal Oak, Michigan 48073
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St. Louis University
Saint Louis, Missouri 63110
Principal Investigator: Adam Fang, MD
Phone: 314-268-5785
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Washington University
Saint Louis, Missouri 63110
Principal Investigator: Darryl Zuckerman, MD
Phone: 314-747-2012
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University of California, San Diego
San Diego, California 92093
Principal Investigator: Jeet Minocha, MD
Phone: 760-685-3600
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Sarasota Memorial Hospital
1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: Justin LEE, MD
Phone: 941-917-1669
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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LSU Health Sciences Center - Shreveport
Shreveport, Louisiana 71130
Principal Investigator: Chaitanya Ahuja, MD
Phone: 318-675-7298
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Spartanburg Regional Medical Center
101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Principal Investigator: Kyran Dowling, MD
Phone: 864-560-1046
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Overlook Medical Center
Summit, New Jersey 07901
Principal Investigator: Clifford Sales, MD
Phone: 908-522-6278
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University Hospital/SUNY Upstate
Syracuse, New York 13210
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Tallahasse Memorial Hospital
Tallahassee, Florida 32308
Principal Investigator: Robert Brumberg, MD
Phone: 850-877-8539
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University of Oklahoma - Tulsa
Tulsa, Oklahoma 74104
Principal Investigator: Rafael D Malgor, MD
Phone: 918-634-7500
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Carle Heart & Vascular Institute
Urbana, Illinois 61801
Principal Investigator: Jeremy Hogg
Phone: 217-383-6622
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Medstar Georgetown
Washington, District of Columbia 20007
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St. Marys Medical Center
West Palm Beach, Florida 33407
Principal Investigator: Lawrence Lottenberg, MD
Phone: 561-882-6150
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Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
Principal Investigator: Kevin Dickey, MD
Phone: 336-716-0308
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