Cook IVC Filter Study
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Günther Tulip® Vena Cava FilterDevice: Cook Celect® Vena Cava Filters
- Registration Number
- NCT02046096
- Lead Sponsor
- Cook Research Incorporated
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
- Requires temporary or permanent IVC filter placement for the prevention of PE
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Günther Tulip® Vena Cava Filter Günther Tulip® Vena Cava Filter Günther Tulip® Vena Cava Filter Cook Celect® Vena Cava Filters Cook Celect® Vena Cava Filters Cook Celect® Vena Cava Filters
- Primary Outcome Measures
Name Time Method The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling. 12 months The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
The Rate of 12-month Freedom From Major Adverse Events (MAEs) 12 months MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.
Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.
Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs). 12 months MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
A filter retrieval is considered a successful safety result through 12 months, regardless of when the retrieval occurred.
- Secondary Outcome Measures
Name Time Method Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata) 12 months MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.
Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.
Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.
Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.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. 12 months Filter interaction with IVC is defined as :
Grade 2: Filter strut is entirely outside of the IVC lumen and within the retroperitoneum as evidenced by a "halo" of retroperitoneal fat around axially viewed strut.
Grade 3: Filter strut is touching, impressing, or perforating another organ (e.g., liver, bowel, aorta, psoas muscle, vertebral body, lymph nodes).
Filter migration : Change in filter position compared to its deployed position (cranial or caudal).
Filter fracture : Any loss of structural integrity (breakage or separation) of the filter identified by imaging or autopsy. Documented by imaging or at autopsy.
Filter embolization : Post-placement movement of the filter or its components to a distant anatomic site completely out of the target zone (i.e., heart/lungs). Documented by imaging or autopsy.Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling 12 months Rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling for the combined patient population (i.e., the Celect and Günther Tulip strata).
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Trial Locations
- Locations (28)
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
OSF St. Francis/Peoria Radiology Research and Education Foundation
🇺🇸Peoria, Illinois, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Coastal Vascular and Interventional
🇺🇸Pensacola, Florida, United States
Miami Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Methodist Hospital - Smith Tower
🇺🇸Houston, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
The Royal Liverpool University Hospital
🇬🇧Liverpool, Meyerside, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Abrazo Arrowhead Campus
🇺🇸Phoenix, Arizona, United States
University of Florida Health - Shands
🇺🇸Gainesville, Florida, United States
North Carolina Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States