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Completed

NCT Number: NCT00470626

Celect Vena Cava Filter Clinical Trial

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital, Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celect Vena Cava Filter

Device

Effective filtration of inferior vena cava blood to prevent thromboembolism.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Collaborators

  • Cook Ireland, Ltd.
  • MED Institute, Incorporated
  • William Cook Australia
  • William Cook Europe

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 8, 2007
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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