Celect Vena Cava Filter Clinical Trial
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use|
- Major Adverse Event [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
- Successful Retrieval [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]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).
- Mean Time to Retrieval Attempt [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Vena Cava Filter
Device: Celect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470626
|The Alfred Hospital|
|Melbourne, Australia, 3181|
|RWTH Aachen University|
|Aachen, Germany, D-52057|
|Instituto Nacional de Enfermedades Respiratorias|
|Mexico City, Mexico, 14080|
|Hospital Universitario de Nuevo Leon|
|Monterrey, Mexico, 64460|
|Universitario Zaragoza - Hospital Clinico|
|Zaragoza, Spain, 50009|
|North Hampshire Hospital|
|Hampshire, United Kingdom, RG24 9NA|
|Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom, LS97TF|
|John Radcliffe Hospital|
|Oxford, United Kingdom, OX3 9DU|
|Principal Investigator:||R.W. Gunther, Prof.||Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen|