The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Effective filtration of inferior vena cava blood to prevent thromboembolism.
The Alfred Hospital
Melbourne, Australia
RWTH Aachen University
Aachen, Germany
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico
Hospital Universitario de Nuevo Leon
Monterrey, Mexico
Major Adverse Event
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Time frame: up to 12 months
Successful Retrieval
Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).
Time frame: up to 12 months
Mean Time to Retrieval Attempt
Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made.
Time frame: up to 12 months
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Universitario Zaragoza - Hospital Clinico
Zaragoza, Spain
North Hampshire Hospital
Hampshire, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom