Pulmonary EmbolismPhase 3RETRIEVE 2NCT01120509
Crux Biomedical Vena Cava Filter Study - United States
A Phase 3 study testing Inferior Vena Cava Filter in people with Pulmonary Embolism, run by Crux Biomedical at 17 sites in United States.
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
- 88 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 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 or legal guardian must provide written informed consent
- At least one of the following conditions
- Proven PE
- Recurrent PE despite adequate anticoagulation
- Contraindication to anticoagulation
Show all 21Show fewer
- Inability to achieve/maintain therapeutic anticoagulation
- Iliocaval DVT
- Large, free-floating proximal DVT
- Massive PE treated with thrombolysis/thrombectomy
- Chronic PE treated with thrombectomy
- Procetion during thrombolysis for iliocaval DVT
- PE with limited cardiopulmonary reserve
- Poor compliance with anticoagulation medication
- High risk of injury worsend by anticoagulation
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE
- Patient has documented vena cava diameter of 17-28mm
- Patient has IVC anatomy suitable for infra-renal placement
- Patient 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 te renal veins
- Duplicate IVC
- Gonadal vein thrombosis
Show all 19Show fewer
- Requires supra-renal placement
- 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 safe 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Albany Medical Center
Albany, New York, 12208
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Atlanta Medical Center
Atlanta, Georgia, 30312
University Hospital
Augusta, Georgia, 30901
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
University of Virginia Medical Center
Charlottesville, Virginia
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Florida Medical Center
Gainesville, Florida, 32610
Hershey Medical Center
Hershey, Pennsylvania, 17033
Christiana Care
Newark, Delaware
St. Joseph's Hospital
Orange, California, 92868
University of California at Irvine Medical Center
Orange, California, 92868
St. Francis Hospital
Peoria, Illinois, 61637
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Univeristy of California at Davis Medical Center
Sacramento, California, 95817
Upstate Medical Center
Syracuse, New York, 13210
Jobst Vascular Institute
Toledo, Ohio, 43606
About this study
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
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 (4)
Retrieval Success
Measured: 6 Months
Filter Migration
Measured: 6 Months
VCF Thrombus
Measured: 6 Months
Device Integrity
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 startJun 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crux Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Mendes, MD, Principal investigator, University Hospital, Augusta, Georgia, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120509
- Sponsor's protocol ID
- Crux02
- Acronym
- RETRIEVE 2
- Status last verified
- Aug 2012
- First submitted
- 29 Apr 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 2
- ClinicalTrials.gov ID
- NCT01120509
- Acronym / sponsor ID
- RETRIEVE 2 / Crux02
- 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
- 88 participants (actual)
- Lead sponsor
- Crux BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 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 (21 listed)
- Patient has a permanent or temporary risk of Pulmonary Embolism
- Patient or legal guardian must provide written informed consent
- At least one of the following conditions
- Patient has documented vena cava diameter of 17-28mm
- Patient has IVC anatomy suitable for infra-renal placement
Key exclusion criteria (19 listed)
- Age <18 years old
- Patient has any one of the following conditions
- Uncontrolled infectious disease
- Risk of aseptic PE
- Uncontrolled coagulopathy
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.
4 secondary outcomes
Retrieval Success
Time frame: 6 Months
Filter Migration
Time frame: 6 Months
VCF Thrombus
Time frame: 6 Months
Device Integrity
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.
Robert Mendes, MD principal investigator
University Hospital, Augusta, Georgia, USA
17 sites in 1 country: 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 17 sites in United States.
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 21 inclusion and 19 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 17 sites in United States. 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.