Celect Vena Cava Filter Clinical Trial
This study has been completed.
Sponsor:
Cook
Collaborators:
MED Institute, Incorporated
William Cook Australia
William Cook Europe
Cook Ireland, Ltd.
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00470626
First received: September 14, 2005
Last updated: April 12, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|
|
Pulmonary Embolism Venous Thromboembolism |
Device: Celect Vena Cava Filter |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 129 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Vena Cava Filter
|
Device: Celect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter.
- The patient must have a patent internal jugular vein.
- The patient or guardian must have given informed consent.
- The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months.
- The patient must agree to have a clinical and imaging examination performed prior to filter retrieval.
- The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval.
Exclusion Criteria:
- The patient is less than 18 years of age.
- The patient is pregnant.
- The patient has uncontrollable coagulopathy.
- The patient has a life expectancy less than 6 months.
- The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
- The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters.
- The patient has a contrast allergy that can not be adequately pre-medicated.
- The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470626
Locations
| Australia | |
| The Alfred Hospital | |
| Melbourne, Australia, 3181 | |
| Germany | |
| RWTH Aachen University | |
| Aachen, Germany, D-52057 | |
| Mexico | |
| Instituto Nacional de Enfermedades Respiratorias | |
| Mexico City, Mexico, 14080 | |
| Hospital Universitario de Nuevo Leon | |
| Monterrey, Mexico, 64460 | |
| 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 | |
Sponsors and Collaborators
Cook
MED Institute, Incorporated
William Cook Australia
William Cook Europe
Cook Ireland, Ltd.
Investigators
| Principal Investigator: | R.W. Gunther, Prof. | Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen |
More Information
Publications:
| Responsible Party: | Michael Seest, William Cook Europe |
| ClinicalTrials.gov Identifier: | NCT00470626 History of Changes |
| Other Study ID Numbers: | 05-507, 110006, GTMX |
| Study First Received: | September 14, 2005 |
| Results First Received: | February 3, 2010 |
| Last Updated: | April 12, 2010 |
| 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 |
Keywords provided by Cook:
|
Pulmonary Embolism Venous Thromboembolism Inferior Vena Cava Filter IVC PE |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 23, 2013