Pulmonary EmbolismNCT00470626
Celect Vena Cava Filter Clinical Trial
A study testing Celect Vena Cava Filter in people with Pulmonary Embolism and Venous Thromboembolism, run by Cook Group Incorporated at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- Celect Vena Cava Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Nov 2005to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United Kingdom3 sites
North Hampshire Hospital
Hampshire, RG24 9NA
Leeds Teaching Hospitals NHS Trust
Leeds, LS97TF
John Radcliffe Hospital
Oxford, OX3 9DU
Mexico2 sites
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14080
Hospital Universitario de Nuevo Leon
Monterrey, 64460
About this study
Official title: Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
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.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Being tested
- Celect Vena Cava Filter
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celect Vena Cava FilterDevice
Effective filtration of inferior vena cava blood to prevent thromboembolism.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vena Cava Filter Receives: Device: Celect Vena Cava Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Event
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Measured: up to 12 months
Secondary outcomes (2)
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).
Measured: up to 12 months
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startNov 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MED Institute, Incorporated, William Cook Australia, William Cook Europe, Cook Ireland, Ltd.
- Responsible party
- Sponsor
- Investigators
- R.W. Gunther, Prof., Principal investigator, Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470626
- Sponsor's protocol ID
- 05-507
- Other IDs
- 110006, GTMX
- Status last verified
- Dec 2015
- First submitted
- 14 Sep 2005
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19875061
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
- ClinicalTrials.gov ID
- NCT00470626
- Acronym / sponsor ID
- 05-507
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- MED Institute, Incorporated, William Cook Australia, William Cook Europe, Cook Ireland, Ltd.
- Study start
- Nov 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 May 2007 (estimated)
- Results
- Posted 6 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Celect Vena Cava FilterVena Cava Filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celect Vena Cava FilterEffective filtration of inferior vena cava blood to prevent thromboembolism. | Device | 1 |
Primary outcome
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.
2 secondary outcomes
Successful Retrieval
Time frame: up to 12 months
Mean Time to Retrieval Attempt
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19875061Lyon 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.
Related trials for Pulmonary Embolism
Active, not recruitingPhase 3
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Pulmonary Embolism
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
Not yet recruitingPhase 2
Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis
Erythrocytosis, Pulmonary Hypertension
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R.W. Gunther, Prof. principal investigator
Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celect Vena Cava Filter in people with Pulmonary Embolism and Venous Thromboembolism, run by Cook Group Incorporated at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Mexico, Australia, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Event (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00470626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.