Celect Vena Cava Filter Clinical Trial

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470626
• Other study ID #: 05-507
• Secondary ID: 110006, GTMX
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: December 21, 2015
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: December 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Ethics CommissionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne
Germany	RWTH Aachen University	Aachen
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico City
Mexico	Hospital Universitario de Nuevo Leon	Monterrey
Spain	Universitario Zaragoza - Hospital Clinico	Zaragoza
United Kingdom	North Hampshire Hospital	Hampshire
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (5)

Lead Sponsor	Collaborator
Cook	Cook Ireland, Ltd., MED Institute, Incorporated, William Cook Australia, William Cook Europe

Countries where clinical trial is conducted

Australia,  Germany,  Mexico,  Spain,  United Kingdom, 

References & Publications (1)

Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Plant GR, De Gregorio MA, Günther 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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).	up to 12 months	No
Secondary	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.	up to 12 months	No