Clinical trial NCT00470626: Celect Vena Cava Filter Clinical Trial
Official title: Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Venous Thromboembolism
Keywords: Pulmonary Embolism
Venous Thromboembolism
Inferior Vena Cava Filter
IVC
PE
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: MED Institute, Incorporated
name: William Cook Australia
name: William Cook Europe
name: Cook Ireland, Ltd.
First posted: 2007-05-08
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Major Adverse Event
timeFrame: up to 12 months
Secondary outcomes:
measure: Successful Retrieval
timeFrame: up to 12 months
measure: Mean Time to Retrieval Attempt
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo Leon
city: Zaragoza
country: Spain
facility: Universitario Zaragoza - Hospital Clinico
city: Hampshire
country: United Kingdom
facility: North Hampshire Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
name: R.W. Gunther, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.