Clinical trial NCT02046096: Cook IVC Filter Study
Official title: Cook IVC Filter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Venous thrombosis
pulmonary embolism
vena cava, inferior
vena cava filters
venous thromboembolism
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).


Eligibility criteria: Inclusion Criteria:

* Requires temporary or permanent IVC filter placement for the prevention of PE

Exclusion Criteria:

* Less than 18 years of age
* Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
* Known allergy or sensitivity to cobalt, chromium, or nickel
* Pregnant or planning to become pregnant in the next 12 months
* Patient refuses blood transfusions
* At risk of septic embolism
* Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
* Existing IVC filter
* Duplicate IVC
* Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
* IVC diameter \> 30 mm or \< 15 mm

Primary outcomes:
measure: The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
timeFrame: 12 months
measure: The Rate of 12-month Freedom From Major Adverse Events (MAEs)
timeFrame: 12 months
measure: Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
timeFrame: 12 months
measure: Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
timeFrame: 12 months
measure: Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month.
timeFrame: 12 months
Other outcomes:
measure: Filter Retrieval Rate
timeFrame: 2 years
Locations:
city: Phoenix
country: United States
facility: Abrazo Arrowhead Campus
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida Health - Shands
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis/Peoria Radiology Research and Education Foundation
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Memorial Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
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
state: Rhode Island
city: Houston
country: United States
facility: The Methodist Hospital - Smith Tower
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
state: Meyerside
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: OSF St. Francis/Peoria Radiology Research and Education Foundation
name: H. Bob Smouse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida Health-Shands
name: Robert Feezor, MD
role: PRINCIPAL_INVESTIGATOR
References: