NCT00470626

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 6, 2010

Completed
Last Updated

January 25, 2016

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

September 14, 2005

Results QC Date

February 3, 2010

Last Update Submit

December 21, 2015

Conditions

Pulmonary EmbolismVenous Thromboembolism

Keywords

Pulmonary EmbolismVenous ThromboembolismInferior Vena Cava FilterIVCPE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Successful Retrieval

    up to 12 months

  • Mean Time to Retrieval Attempt

    up to 12 months

Study Arms (1)

1

EXPERIMENTAL

Vena Cava Filter

Device: Celect Vena Cava Filter

Interventions

Celect Vena Cava FilterDEVICE

Effective filtration of inferior vena cava blood to prevent thromboembolism.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The Alfred Hospital

Melbourne, 3181, Australia

Location

RWTH Aachen University

Aachen, D-52057, Germany

Location

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

Location

Hospital Universitario de Nuevo Leon

Monterrey, 64460, Mexico

Location

Universitario Zaragoza - Hospital Clinico

Zaragoza, 50009, Spain

Location

North Hampshire Hospital

Hampshire, RG24 9NA, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS97TF, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19875061RESULT

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Results Point of Contact

Title
Scott Snyder
Organization
Cook
ssnyder@medinst.com
765-463-7537

Study Officials

  • R.W. Gunther, Prof.

    Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

May 8, 2007

Study Start

November 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 25, 2016

Results First Posted

April 6, 2010

Record last verified: 2015-12

Locations

GB(3)DE(1)AU(1)ES(1)ME(2)