Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
PRESERVE
1 other identifier
observational
1,428
1 country
53
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedOctober 4, 2021
September 1, 2021
4.5 years
March 2, 2015
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event
Clinically significant perforation is defined as protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ or that triggers the decision to remove the filter; resulting in an attempt to remove the IVC filter or requiring other intervention. Filter embolization is defined as movement of the filter or its components to a distant anatomic site completely out of the target zone after successful filter placement, confirmed by imaging. Caval thrombotic occlusion is defined as presence of an occluding thrombus in the IVC after filter insertion and documented by ultrasound (US), computed tomography (CT), magnetic resonance (MR) imaging, venography, or autopsy; this may be symptomatic or asymptomatic after successful filter placement. Deep vein thrombosis (DVT) is defined as new symptomatic DVT post-deployment, as determined by standard of care imaging. Serious adverse event is defined by ISO 14155.
Within first 365 days (± 30 days)
Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism
New symptomatic PE confirmed by appropriate imaging
At 12-months in-situ or 1-month post-retrieval (whichever comes first)
Secondary Outcomes (6)
Mechanical Stability
At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Procedure-related complications
At 3-months
Major adverse events (composite and individual components)
At 3-months, 6-months, 12-months, 18-months, and 24-months
Filter tilting >15°
At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Filter retrieval
Up to 24-months
- +1 more secondary outcomes
Study Arms (1)
IVC Filter
IVC filter for the prevention of PE
Interventions
Eligibility Criteria
Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carelon Researchlead
- ALN Implants Chirurgicauxcollaborator
- B. Braun Interventional Systems, Inccollaborator
- Bard Peripheral Vascular, Inc.collaborator
- Cook Group Incorporatedcollaborator
- Cordis US Corp.collaborator
- Argon Medical Devicescollaborator
- Society of Interventional Radiology Foundationcollaborator
- Society for Vascular Surgerycollaborator
Study Sites (53)
University of Arkansas
Little Rock, Arkansas, 72205, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, 90024, United States
Palo Alto VA
Palo Alto, California, 94304, United States
University of California San Francisco
San Francisco, California, 94118, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06501, United States
Medstar Georgetown
Washington D.C., District of Columbia, 20007, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33301, United States
The Heart Institute Largo
Largo, Florida, 33770, United States
University of Miami Hospital and Clinics/Jackson Memorial
Miami, Florida, 33136, United States
Florida Hospital
Orlando, Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Tallahasse Memorial Hospital
Tallahassee, Florida, 32308, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Carle Heart & Vascular Institute
Urbana, Illinois, 61801, United States
Indiana University
Indianapolis, Indiana, 46202, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71130, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Massachusetts General Hospital
Boston, Massachusetts, 02446, United States
Southcoast Hospital
North Dartmouth, Massachusetts, 02747, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Louis University
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
Hackensack UMC
Hackensack, New Jersey, 07601, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Albany Medical Center
Albany, New York, 12208, United States
Feinstein Institute
Manhasset, New York, 11030, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NY Presbyterian Weil Cornell Medical Ctr
New York, New York, 10065, United States
Rochester Regional Health System
Rochester, New York, 14621, United States
University Hospital/SUNY Upstate
Syracuse, New York, 13210, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Miami Valley Hospital/Wright State University
Dayton, Ohio, 45409, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
University of Oklahoma-Tulsa
Tulsa, Oklahoma, 74104, United States
Oregon Health & Science Center
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital/Miriam Hospital
Providence, Rhode Island, 02903, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
UT Southwestern
Dallas, Texas, 75390, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Medical College of WI/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):573-585.e6. doi: 10.1016/j.jvsv.2022.11.002. Epub 2023 Feb 23.
PMID: 36872169DERIVEDJohnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Interv Radiol. 2023 Apr;34(4):517-528.e6. doi: 10.1016/j.jvir.2022.12.009. Epub 2023 Feb 23.
PMID: 36841633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David L. Gillespie, MD, FACS
Cape Cod Hospital
- STUDY CHAIR
Matt Johnson, MD
Indiana University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 6, 2015
Study Start
October 1, 2015
Primary Completion
March 17, 2020
Study Completion
September 20, 2021
Last Updated
October 4, 2021
Record last verified: 2021-09