Pulmonary EmbolismPhase 2RetrieveNCT00605332
Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve)
A Phase 2 study testing inferior vena cava filter in people with Pulmonary Embolism, run by Crux Biomedical.
Trial summary
This is an open label, non-randomized, prospective, multicenter study. 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
- No sites listed yet
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 2
- 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
- Patients for this study must meet the following inclusion criteria to be eligible for enrollment:
- The patient is >18 years of age.
- Patient is considered a candidate for the IVCF under one of the following indications:
- Proven PE
- Recurrent PE despite adequate anticoagulation
- Contraindication to anticoagulation
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- Inability to achieve/maintain therapeutic anticoagulation
- Iliocaval DVT
- Large, free-floating proximal (i.e. ileofemoral) 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 anticoagulant medications
- High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE
- Patient has a vena cava diameter of 17-28mm.
- The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
- The patient is willing to be available for the appropriate follow-up for the duration of the study.
- The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.
Who cannot join
- Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
- The patient has one of the following conditions:
- Renal vein thrombosis
- IVC thrombosis extending to renal veins
- Duplicate IVC
- Gonadal vein thrombosis
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- Requires supra-renal filter placement
- The patient has an uncontrolled infectious disease.
- The patient is at risk for aseptic PE.
- Patient has uncontrollable coagulopathy.
- Patient has an existing IVCF.
- The patient has a life expectancy of less than 6 months.
- The patient is pregnant.
- The patient has a condition that inhibits radiographic visualization of the IVC.
- The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
- The patient has a known hypersensitivity to contrast which cannot be pre-treated.
- The patient's access vessels preclude safe insertion of the delivery system.
- The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
- The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.
About this study
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")
This is an open label, non-randomized, prospective, multicenter study.
- Conditions
- Pulmonary Embolism
- Being tested
- inferior vena cava filter
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior vena cava filterDevice
Also called No other names
Crux Biomedical IVC Filter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Investigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of 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.
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.
Measured: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.
Secondary outcomes (1)
Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF.
Measured: 30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2009
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- 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
- David Rosenthal, MD, Principal investigator, Atlanta Vascular SpecialistsMel Schatz, Study director, Crux Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605332
- Sponsor's protocol ID
- RETRIEVE I
- Other IDs
- G070035
- Acronym
- Retrieve
- Status last verified
- Aug 2012
- First submitted
- 2 Jan 2008
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. 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 - ("Retrieve")
- ClinicalTrials.gov ID
- NCT00605332
- Acronym / sponsor ID
- Retrieve / RETRIEVE I
- Conditions
- Pulmonary Embolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Crux BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Jan 2008 (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.
This is an open label, non-randomized, prospective, multicenter study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: inferior vena cava filterInvestigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of pulmonary embolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients for this study must meet the following inclusion criteria to be eligible for enrollment:
- The patient is >18 years of age.
- Patient is considered a candidate for the IVCF under one of the following indications:
- Patient has a vena cava diameter of 17-28mm.
- The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
Key exclusion criteria (19 listed)
- The patient has one of the following conditions:
- The patient has an uncontrolled infectious disease.
- The patient is at risk for aseptic PE.
- Patient has uncontrollable coagulopathy.
- Patient has an existing IVCF.
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 filterAlso: No other namesCrux Biomedical IVC Filter | Device | 1 |
Primary outcome
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.
Time frame: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.
1 secondary outcome
Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF.
Time frame: 30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.
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 6 Aug 2012.
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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.
David Rosenthal, MD principal investigator
Atlanta Vascular Specialists
Mel Schatz study director
Crux Biomedical
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inferior vena cava filter in people with Pulmonary Embolism, run by Crux Biomedical.
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 22 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 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF. (time frame: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.). 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 6 Aug 2012.