Clinical trial NCT02381509: Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Official title: Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Keywords: inferior vena cava filters
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: ALN Implants Chirurgicaux
name: B. Braun Interventional Systems, Inc
name: Bard Peripheral Vascular, Inc.
name: Cook Group Incorporated
name: Cordis Corporation
name: Argon Medical Devices
name: Society of Interventional Radiology Foundation
name: Society for Vascular Surgery
First posted: 2015-03-06
Enrollment: 1428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Within first 365 days (± 30 days)
measure: Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism
timeFrame: At 12-months in-situ or 1-month post-retrieval (whichever comes first)
Secondary outcomes:
measure: Mechanical Stability
timeFrame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
measure: Procedure-related complications
timeFrame: At 3-months
measure: Major adverse events (composite and individual components)
timeFrame: At 3-months, 6-months, 12-months, 18-months, and 24-months
measure: Filter tilting >15°
timeFrame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
measure: Filter retrieval
timeFrame: Up to 24-months
measure: 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)
timeFrame: At 12-months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: Ronald Regan UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto VA
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Largo
country: United States
facility: The Heart Institute Largo
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics/Jackson Memorial
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahasse Memorial Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Heart & Vascular Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: North Dartmouth
country: United States
facility: Southcoast Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Hackensack
country: United States
facility: Hackensack UMC
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: NY Presbyterian Weil Cornell Medical Ctr
state: New York
city: Rochester
country: United States
facility: Rochester Regional Health System
state: New York
city: Syracuse
country: United States
facility: University Hospital/SUNY Upstate
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital/Wright State University
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Tulsa
country: United States
facility: University of Oklahoma-Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science Center
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital/Miriam Hospital
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of WI/Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Cape Cod Hospital
name: David L. Gillespie, MD, FACS
role: STUDY_CHAIR
affiliation: Indiana University School of Medicine
name: Matt Johnson, MD
role: STUDY_CHAIR
References: