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Celect Vena Cava Filter Clinical Trial

Primary Purpose

Pulmonary Embolism, Venous Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Celect Vena Cava Filter
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Alfred Hospital
  • RWTH Aachen University
  • Instituto Nacional de Enfermedades Respiratorias
  • Hospital Universitario de Nuevo Leon
  • Universitario Zaragoza - Hospital Clinico
  • North Hampshire Hospital
  • Leeds Teaching Hospitals NHS Trust
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Vena Cava Filter

Outcomes

Primary Outcome Measures

Major Adverse Event
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
September 14, 2005
Last Updated
December 21, 2015
Sponsor
Cook Group Incorporated
Collaborators
MED Institute, Incorporated, William Cook Australia, William Cook Europe, Cook Ireland, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00470626
Brief Title
Celect Vena Cava Filter Clinical Trial
Official Title
Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
MED Institute, Incorporated, William Cook Australia, William Cook Europe, Cook Ireland, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Venous Thromboembolism
Keywords
Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Vena Cava Filter
Intervention Type
Device
Intervention Name(s)
Celect Vena Cava Filter
Intervention Description
Effective filtration of inferior vena cava blood to prevent thromboembolism.
Primary Outcome Measure Information:
Title
Major Adverse Event
Description
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Successful Retrieval
Description
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).
Time Frame
up to 12 months
Title
Mean Time to Retrieval Attempt
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R.W. Gunther, Prof.
Organizational Affiliation
Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3181
Country
Australia
Facility Name
RWTH Aachen University
City
Aachen
ZIP/Postal Code
D-52057
Country
Germany
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario de Nuevo Leon
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Universitario Zaragoza - Hospital Clinico
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
North Hampshire Hospital
City
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19875061
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.
Results Reference
result

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Celect Vena Cava Filter Clinical Trial

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