Pulmonary EmbolismNCT02394912
Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System
A study testing vena cava filter implantation (LUMIFI with Crux VCF System) in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Volcano Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- vena cava filter implantation (LUMIFI with Crux VCF System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to 9 Nov 2016
- 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
- Patient is >18 years of age.
- Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
- Patient has appropriate femoral vein access
- Patient at risk for PE and meets at least one of the following sets of conditions:
- Documented DVT or PE and: i. Inability to anticoagulate the patient due to risk of bleeding such as recent surgery, trauma, intracranial bleed, GI bleed, OR ii. Progression/recurrence of DVT or PE on therapeutic anticoagulation, OR iii. Inability to anticoagulate due to high risk of tumor bleeding, OR iv. Patient unable to safely comply with anticoagulation, OR v. Patient that needs interruption of therapeutic anticoagulation such as at the time of an operation or other procedure.
- Patient that is high risk for DVT or PE and cannot be safely anticoagulated such as severe multi-trauma patient or patient having procedure with high risk for thromboembolism such as bariatric surgery.
- Patients with DVT at high risk for PE and free floating iliac or caval thrombosis d. Patients with compromised cardiopulmonary reserve from existing PE with right heart failure/strain who could not tolerate any further insult from new PE
Who cannot join
- Patient has any one of the following conditions:
- Thrombus in the iliac veins or the IVC that precludes access to appropriate placement of the Crux Filter
- Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC
- Known duplicated or left-sided IVC
- Known IVC transverse diameter at target lower renal ostia > 28mm or < 17mm
- Known extrinsic compression from abdominal or pelvic mass
Show all 18Show fewer
- Known tumor thrombus involving the central venous system
- Uncontrolled sepsis, infection or persistent bacteremia
- Patient is at risk for septic pulmonary embolism
- Patient has an existing implanted filter in the IVC or superior vena cava (SVC) or underwent filter retrieval in previous 60 days.
- Patient has uncontrollable or active coagulopathy or known uncorrectable bleeding diathesis
- Patient has a condition that inhibits radiographic visualization of the IVC for post-deployment assessment
- Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium)
- Patients unwilling or unable to comply with the protocol
- Patients with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated
- Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
- Patient is participating in another device or drug clinical trial or has participated in such trial in the 30 days prior to enrollment
- Investigator considers patient to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Surgical Care Associates
Louisville, Kentucky, 40207
Vascular Access Solutions
Orangeburg, South Carolina, 29118
About this study
Official title: Evaluation of the Technical Success of Intravascular Ultrasound (IVUS) Guided Vena Cava Filter (VCF) Placement Using the LUMIFI™ With Crux® VCF System (LUMIFI Clinical Study)
The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- vena cava filter implantation (LUMIFI with Crux VCF System)
- Keywords
- vena cava filter
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vena cava filter implantation (LUMIFI with Crux VCF System)Device
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Not described Receives: Device: vena cava filter implantation (LUMIFI with Crux VCF System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism.
Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Why it stopped: Unsatisfactory filter deployment in several cases
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.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Jacobs, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394912
- Sponsor's protocol ID
- 140201
- Status last verified
- Jul 2019
- First submitted
- 5 Mar 2015
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Technical Success of Intravascular Ultrasound (IVUS) Guided Vena Cava Filter (VCF) Placement Using the LUMIFI™ With Crux® VCF System (LUMIFI Clinical Study)
- ClinicalTrials.gov ID
- NCT02394912
- Acronym / sponsor ID
- 140201
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Keywords
- vena cava filter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsatisfactory filter deployment in several cases
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 11 Jun 2018
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 evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: vena cava filter implantation (LUMIFI with Crux VCF System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is >18 years of age.
- Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
- Patient has appropriate femoral vein access
- Patient at risk for PE and meets at least one of the following sets of conditions:
Key exclusion criteria (18 listed)
- Patient has any one of the following conditions:
- Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium)
- Patients unwilling or unable to comply with the protocol
- Patients with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated
- Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
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 |
|---|---|---|
| vena cava filter implantation (LUMIFI with Crux VCF System) | Device | Single-arm |
Primary outcome
Technical Success Rate
Time frame: Day 1
All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donald Jacobs, MD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vena cava filter implantation (LUMIFI with Crux VCF System) in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Volcano Corporation at 2 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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). 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?
Technical Success Rate (time frame: Day 1). 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 Jul 2019.