Celect Vena Cava Filter Clinical Trial

Overview

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.

Full Title of Study: “Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2009

Interventions

  • Device: Celect Vena Cava Filter
    • Effective filtration of inferior vena cava blood to prevent thromboembolism.

Arms, Groups and Cohorts

  • Experimental: 1
    • Vena Cava Filter

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Collaborator
    • MED Institute, Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • R.W. Gunther, Prof., Principal Investigator, Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen

Citations Reporting on Results

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.

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