Celect Vena Cava Filter Clinical Trial

Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

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 Overview

• Status: Completed
• Conditions: Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Device: Celect Vena Cava Filter

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3181
    • The Alfred Hospital
• Germany
  • Aachen, Germany, D-52057
    • RWTH Aachen University
• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional De Enfermedades Respiratorias
  • Monterrey, Mexico, 64460
    • Hospital Universitario de Nuevo León
• Spain
  • Zaragoza, Spain, 50009
    • Universitario Zaragoza - Hospital Clinico
• United Kingdom
  • Hampshire, United Kingdom, RG24 9NA
    • North Hampshire Hospital
  • Leeds, United Kingdom, LS97TF
    • Leeds Teaching Hospitals NHS Trust
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Vena Cava Filter	Device: Celect Vena Cava Filter; Effective filtration of inferior vena cava blood to prevent thromboembolism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Event	Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Retrieval	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).	up to 12 months
Mean Time to Retrieval Attempt	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.	up to 12 months

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Collaborators: William Cook Europe; MED Institute, Incorporated; William Cook Australia; Cook Ireland, Ltd.
• Investigators: Principal Investigator: R.W. Gunther, Prof., Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen

Publications and helpful links

General Publications

• Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Plant GR, De Gregorio MA, Gunther RW, Voorhees WD, McCann-Brown JA. Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry. J Vasc Interv Radiol. 2009 Nov;20(11):1441-8. doi: 10.1016/j.jvir.2009.07.038.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: May 7, 2007
• First Posted (Estimate): May 8, 2007

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; PE; Pulmonary Embolism; Inferior Vena Cava Filter; IVC
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: 05-507; 110006, GTMX