Celect Vena Cava Filter Clinical Trial

Not Applicable

Completed

• Conditions: Pulmonary Embolism; Venous Thromboembolism
• Interventions: Device: Celect Vena Cava Filter

• Registration Number: NCT00470626
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-14
• Study Start: 2005-11
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-02-03
• Results First Submitted QC: 2010-03-16
• Results First Posted: 2010-04-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Celect Vena Cava Filter	Vena Cava Filter

Primary Outcome Measures

Name	Time	Method
Major Adverse Event	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.

Secondary Outcome Measures

Name	Time	Method
Successful Retrieval	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	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.

Trial Locations

Locations (8)

RWTH Aachen University; 🇩🇪 Aachen, Germany

The Alfred Hospital; 🇦🇺 Melbourne, Australia

Instituto Nacional de Enfermedades Respiratorias; 🇲🇽 Mexico City, Mexico

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

Hospital Universitario de Nuevo Leon; 🇲🇽 Monterrey, Mexico