Pulmonary EmbolismPhase 3RETRIEVE 4NCT01120535
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
A Phase 3 study testing Inferior Vena Cava Filter in people with Pulmonary Embolism, run by Crux Biomedical at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Inferior Vena Cava Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2010to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patient has a permanent or temporary risk of Pulmonary Embolism.
- Patient must provide informed consent At least one of the following conditions -
- Proven PE
- Recurrent PE despite adequate
- Contraindication to anticoagulation
- Inability to achieve/maintain therapeutic anticoagulation
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- Iliocaval DVT
- Large, free-floating proximal DVT
- Massive PE treated with thrombolysis/thrombectomy
- Chronic PE treated with thrombectomy
- Protection during thrombolysis for iliocaval DVT
- PE with limited cardiopulmonary reserve
- Poor compliance with anticoagulation medication
- High risk of injury worsening on anticoagulation
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up
Who cannot join
- Age <18 years old
- Patient has any one of the following conditions:
- Renal vein thrombosis
- IVC thrombosis extending to the renal veins
- Duplicate IVC
- Gonadal vein thrombosis
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- Requires supra-renal placement
- Vena cava diameter of 17-28mm
- Uncontrolled infectious disease
- Risk of aseptic PE
- Uncontrolled coagulopathy
- Existing inferior vena cava filter implant
- Life expectancy less than 6 months
- Pregnant or planning a pregnancy in the next 6 months
- Condition that inhibits radiographic visualization of the IVC
- Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
- Known hypersensitivity to contract which cannot be pretreated
- Access vessels preclude same insertion of delivery system
- Participation in another drug or device trial
- Unable or unwilling to cooperate with study procedures or required follow-up visits
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Royal Brisbane Womens Hospital
Brisbane
The Alfred Hospital
Melbourne
About this study
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
- Conditions
- Pulmonary Embolism
- Being tested
- Inferior Vena Cava Filter
- Keywords
- Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism
- 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.
Inferior Vena Cava FilterDevice
Inplant of filter in inferior vena cava.
| Study group | Role | What they receive |
|---|---|---|
| Crux Vena Cava Filter System | Experimental | Subjects at risk for Pulmonary Embolism Receives: Device: Inferior Vena Cava Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
Measured: 6 Months
Secondary outcomes (1)
Rates of complications related to vena cava filter use.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crux Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120535
- Sponsor's protocol ID
- Crux04
- Acronym
- RETRIEVE 4
- Status last verified
- Feb 2012
- First submitted
- 6 May 2010
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)
- ClinicalTrials.gov ID
- NCT01120535
- Acronym / sponsor ID
- RETRIEVE 4 / Crux04
- Conditions
- Pulmonary Embolism
- Keywords
- Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Crux BiomedicalIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crux Vena Cava Filter System | Experimental | Device: Inferior Vena Cava FilterSubjects at risk for Pulmonary Embolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient has a permanent or temporary risk of Pulmonary Embolism.
- Patient must provide informed consent At least one of the following conditions -
- Proven PE
- Recurrent PE despite adequate
- Contraindication to anticoagulation
Key exclusion criteria (20 listed)
- Age <18 years old
- Patient has any one of the following conditions:
- Vena cava diameter of 17-28mm
- Uncontrolled infectious disease
- Risk of aseptic PE
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 |
|---|---|---|
| Inferior Vena Cava FilterInplant of filter in inferior vena cava. | Device | Crux Vena Cava Filter System |
Primary outcome
Clinical Success
Time frame: 6 Months
Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
1 secondary outcome
Rates of complications related to vena cava filter use.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Smouse H, Mendes R, Bosiers M et al. The RETRIEVE Trial: Safety and Effectiveness of the Retrieval Crux Vena Cava Filter. JVIR 2013; 24:609-621.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inferior Vena Cava Filter in people with Pulmonary Embolism, run by Crux Biomedical at 3 sites in 2 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 17 inclusion and 20 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 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, New Zealand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Success (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.