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Sponsors and Collaborators: |
Cook MED Institute, Incorporated William Cook William Cook Europe Cook Ireland, Ltd. |
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Information provided by: | Cook |
ClinicalTrials.gov Identifier: | NCT00470626 |
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.
Condition | Intervention |
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Pulmonary Embolism Venous Thromboembolism |
Device: Celect Vena Cava Filter |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use |
Estimated Enrollment: | 85 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vena Cava Filter
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Device: Celect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Implant Group):
Inclusion Criteria (Retrieval Group):
Exclusion Criteria (Implant Group):
Exclusion Criteria (Retrieval Group):
Australia | |
The Alfred Hospital | |
Melbourne, Australia, 3181 | |
Germany | |
RWTH Aachen University | |
Aachen, Germany, D-52057 | |
Mexico | |
Hospital Universitario de Nuevo Leon | |
Monterrey, Mexico, 64460 | |
Instituto Nacional de Enfermedades Respiratorias | |
Mexico City, Mexico, 14080 | |
Spain | |
Universitario Zaragoza - Hospital Clinico | |
Zaragoza, Spain, 50009 | |
United Kingdom | |
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 |
Responsible Party: | William Cook Europe ( Michael Seest ) |
Study ID Numbers: | 05-507-01, 110006 |
Study First Received: | September 14, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00470626 |
Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection; Australia: Department of Health and Ageing Therapeutic Goods Administration; Germany: Ethics Commission; Spain: Spanish Agency of Medicines |
Pulmonary Embolism Venous Thromboembolism Inferior Vena Cava Filter IVC PE |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases |
Vascular Diseases Venous Thromboembolism Thrombosis Thromboembolism |
Cardiovascular Diseases |