Celect Vena Cava Filter Clinical Trial
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|ClinicalTrials.gov Identifier: NCT00470626|
Recruitment Status : Completed
First Posted : May 8, 2007
Results First Posted : April 6, 2010
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Venous Thromboembolism||Device: Celect Vena Cava Filter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Vena Cava Filter
Device: Celect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
- Major Adverse Event [ Time Frame: up to 12 months ]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 ]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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|