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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
473
Temporary or permanent filter placement for the prevention of pulmonary embolism
Temporary or permanent filter placement for the prevention of pulmonary embolism
The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
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).
Time frame: 12 months
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
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.
Time frame: 12 months
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
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.
Time frame: 12 months
Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
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Abrazo Arrowhead Campus
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Florida Health - Shands
Gainesville, Florida, United States
Miami Cardiac and Vascular Institute
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Coastal Vascular and Interventional
Pensacola, Florida, United States
University of Chicago
Chicago, Illinois, United States
OSF St. Francis/Peoria Radiology Research and Education Foundation
Peoria, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
...and 18 more locations
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).
Time frame: 12 months
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
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.
Time frame: 12 months
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.
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.
Time frame: 12 months