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 |
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.
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
Tulsa, Oklahoma 74104
Principal Investigator: Rafael D Malgor, MD
Phone: 918-634-7500
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185 Cambridge Street
Boston, Massachusetts 02114
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
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
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
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 While spirituality plays an essential role in the way that we minister...
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425 University Blvd.
Indianapolis, Indiana 46202
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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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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3400 Spruce St
Philadelphia, Pennsylvania 19104
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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1000 W Carson St
Torrance, California 90502
Torrance, California 90502
Principal Investigator: Rodney A White, MD
Phone: 310-222-5249
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Albany, New York 12208
Principal Investigator: Gary Siskin, MD
Phone: 518-262-5356
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500 S State St
Ann Arbor, Michigan 48109
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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Aurora, Colorado 80045
Principal Investigator: Paul Rochon, MD
Phone: 720-848-6137
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Boston, Massachusetts 02118
Principal Investigator: Jeffrey Kalish, MD
Phone: 617-414-6832
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251 E Huron St
Chicago, Illinois 60611
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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Dayton, Ohio 45409
Principal Investigator: Shannon Kauffman, MD
Phone: 937-208-6013
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Durham, North Carolina 27708
Principal Investigator: David Sopko, MD
Phone: 919-684-7277
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Hackensack, New Jersey 07601
Principal Investigator: Gregory Simonian, MD
Phone: 551-996-5722
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Houston, Texas 77030
Principal Investigator: Alan Cohen, MD
Phone: 713-500-7073
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401 N Ewing St
Lancaster, Ohio 43130
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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Largo, Florida 33770
Principal Investigator: Merrill Krolick, MD
Phone: 727-489-5416
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Los Angeles, California 90095
Principal Investigator: John Moriarty, MD
Phone: 310-794-8334
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Manhasset, New York 11030
Principal Investigator: Eric Gandras, MD
Phone: 516-881-7022
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8701 West Watertown Plank Road
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Principal Investigator: Eric Hohenwalter, MD
Phone: 414-805-2077
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20 York St, N20 York St,
New Haven, Connecticut 06520
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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New York, New York 10065
Principal Investigator: David Trost, MD
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
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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North Dartmouth, Massachusetts 02747
Principal Investigator: Michael Ayad, MD
Phone: 281-827-1985
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601 E Rollins St
Orlando, Florida 32803
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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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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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Portland, Oregon 97239
Principal Investigator: John Kaufman, MD
Phone: 503-494-7226
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Providence, Rhode Island 02903
Principal Investigator: Timothy P Murphy, MD
Phone: 401-444-1739
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Rochester, Minnesota 55905
Principal Investigator: Haraldur Bjarnason, MD
Phone: 507-538-0540
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Rochester, New York 14621
Principal Investigator: Donnette Dabydeen
Phone: 585-747-2713
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Saint Louis, Missouri 63110
Principal Investigator: Adam Fang, MD
Phone: 314-268-5785
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Saint Louis, Missouri 63110
Principal Investigator: Darryl Zuckerman, MD
Phone: 314-747-2012
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San Diego, California 92093
Principal Investigator: Jeet Minocha, MD
Phone: 760-685-3600
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San Francisco, California 94143
Principal Investigator: Pallav Kolli, MD
Phone: 415-353-2310
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1700 S Tamiami Trail
Sarasota, Florida 34239
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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Shreveport, Louisiana 71130
Principal Investigator: Chaitanya Ahuja, MD
Phone: 318-675-7298
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101 E Wood St
Spartanburg, South Carolina 29303
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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Summit, New Jersey 07901
Principal Investigator: Clifford Sales, MD
Phone: 908-522-6278
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Tallahassee, Florida 32308
Principal Investigator: Robert Brumberg, MD
Phone: 850-877-8539
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Urbana, Illinois 61801
Principal Investigator: Jeremy Hogg
Phone: 217-383-6622
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West Palm Beach, Florida 33407
Principal Investigator: Lawrence Lottenberg, MD
Phone: 561-882-6150
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Winston-Salem, North Carolina 27157
Principal Investigator: Kevin Dickey, MD
Phone: 336-716-0308
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