Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
- Conditions
- Pulmonary EmbolismDeep Vein Thrombosis
- Interventions
- Device: IVC Filter
- Registration Number
- NCT02381509
- Lead Sponsor
- Carelon Research
- 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.
- Detailed Description
The overall goal is to characterize the current practice of IVC filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of PE and recurrence of DVT. The first steps are to identify the characteristics of use in a broad range of clinical practice settings in the US.
Commercially available IVC filters from 6 manufacturers in the United States will be used. The type of FDA-cleared IVC filter implanted will be left to the discretion of the Principal Investigator at the Site. The following IVC filters will be utilized in this trial:
1. ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)
2. Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)
3. VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter
4. DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)
5. Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)
6. Cordis OPTEASE® Retrievable Vena Cava Filter and Cordis TRAPEASE® Permanent Vena Cava Filter (Cordis Corporation)
Subjects will be evaluated at Procedure, Discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month postretrieval. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1428
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IVC Filter IVC Filter IVC filter for the prevention of PE
- Primary Outcome Measures
Name Time Method 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 Within first 365 days (± 30 days) 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.
Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism At 12-months in-situ or 1-month post-retrieval (whichever comes first) New symptomatic PE confirmed by appropriate imaging
- Secondary Outcome Measures
Name Time Method Mechanical Stability At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval Defined by absence of: 1) Migration: cephalad movement of the filter \>20mm relative to fixed anatomic landmarks compared to the time of placement, 2) Migration: caudal migration of the filter \>20mm relative to fixed anatomic landmarks compared to the time of placement, 3) Perforation: \>5mm outside apparent cava wall as determined by CT or perforation of adjacent viscera or major vessel, 4) Filter fracture: any loss of a filter's structural integrity (i.e. breakage or separation) documented by imaging or autopsy, 5) Filter embolization: post-deployment movement of the filter or its components to a distant anatomic site completely out of the target zone
Procedure-related complications At 3-months In the judgment of the Principal Investigator
Filter tilting >15° At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval As determined by appropriate imaging
Secondary Effectiveness Endpoint for each IVC filter brand tested only if the study is a success (i.e., both primary safety and effectiveness endpoints have been met) At 12-months PE rate
Major adverse events (composite and individual components) At 3-months, 6-months, 12-months, 18-months, and 24-months Defined as death, PE, caval thrombotic occlusion, DVT, clinically significant perforation, retroperitoneal hematoma, or adjacent organ penetration
Filter retrieval Up to 24-months Includes: Attempted retrieval, Successful retrieval, Failed retrieval, Percentage of retrieval success, Complications associated with filter retrieval, Reasons for failed retrieval
Trial Locations
- Locations (53)
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Rochester Regional Health System
🇺🇸Rochester, New York, United States
The Heart Institute Largo
🇺🇸Largo, Florida, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Palo Alto VA
🇺🇸Palo Alto, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Carle Heart & Vascular Institute
🇺🇸Urbana, Illinois, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
University of Oklahoma-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Ronald Regan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Medstar Georgetown
🇺🇸Washington, District of Columbia, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Miami Valley Hospital/Wright State University
🇺🇸Dayton, Ohio, United States
NY Presbyterian Weil Cornell Medical Ctr
🇺🇸New York, New York, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Miami Hospital and Clinics/Jackson Memorial
🇺🇸Miami, Florida, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Health & Science Center
🇺🇸Portland, Oregon, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Feinstein Institute
🇺🇸Manhasset, New York, United States
University Hospital/SUNY Upstate
🇺🇸Syracuse, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Medical College of WI/Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Tallahasse Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Southcoast Hospital
🇺🇸North Dartmouth, Massachusetts, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Rhode Island Hospital/Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States