Deep Vein ThrombosisVERITASNCT01787773
VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism
A study testing Veniti Inferior Vena Cava Filter in people with Deep Vein Thrombosis and Pulmonary Embolus, run by Veniti at 2 sites in 2 countries.
Trial summary
This is a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolus
- What is being tested?
- Veniti Inferior Vena Cava Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to Apr 2017
- Phase
- Interventional
- 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
- ≥ 18 years
- Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following:
- Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has:
- Pulmonary embolus
- Iliocaval deep vein thrombosis (DVT)
- Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures
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- Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery
- Past history of thromboembolic disease undergoing surgery
- Therapeutic anticoagulation can be achieved, but the patient has:
- Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve
- Massive pulmonary embolism already treated with thrombectomy or any thrombolytic therapy
- Chronic pulmonary embolism already treated with thrombectomy
- Large, free floating proximal, e.g., iliofemoral or iliocaval, DVT
- Iliocaval DVT with planned catheter thrombectomy or thrombolysis treatment OR
- Medical condition with high risk of venous thromboembolism
Who cannot join
- Condition that inhibits radiographic visualization of the IVC
- Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins
- Known IVC transverse diameter at target implant site > 28 mm
- Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter
- Known duplication of IVC or left-sided IVC
- Severe kyphosis or scoliosis
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- Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis
- Risk for septic pulmonary embolism
- Confirmed bacteremia
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent.
- Contrast agent allergy that cannot be adequately pre-medicated
- Known hypersensitivity to Nitinol (nickel-titanium), platinum, Polyether ether ketone (PEEK), UV Cure Adhesive or Cyanoacrylate Adhesive
- Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
- Life expectance < 6 months
- Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study. (If a female of child bearing potential wishes to participate, she must have negative pregnancy test within 48 hours of the implantation and any retrieval procedures.)
- Has filter in place or underwent filter retrieval in previous 60 days
- Simultaneously participating in another therapeutic drug or device 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 that including the patient may compromise the study, e.g., suspect patient may not comply with follow up procedures, concomitant conditions
- Patient does not wish to consent to study or comply with study procedures, including possible 2 year follow up
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients.
Read the detailed description
Verify the effectiveness and safety of the Veniti IVC Filter in accordance with the clinical guidelines published by the Society for Interventional Radiology (SIR) .
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of:
- Procedure failure (assessed at the end of the implant procedure)
- Subsequent pulmonary embolus
- IVC occlusion
- Filter embolization
Secondary assessments include:
Estimating the rate of:
- Retrieval success
- Device and procedure related adverse events
- Assessing filter performance rate: c1.Filter migration c2.Filter fracture c3.Filter Tilt
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Being tested
- Veniti Inferior Vena Cava Filter
- Keywords
- Inferior Vena Cava Filter, Vena Cava Filters
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veniti Inferior Vena Cava FilterDevice
| Study group | Role | What they receive |
|---|---|---|
| Veniti Inferior Vena Cava Filter | Experimental | Not described Receives: Device: Veniti Inferior Vena Cava Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of:
- Procedure failure (assessed at the end of the implant procedure)
- Subsequent pulmonary embolus
- IVC occlusion
- Filter embolization
Measured: 6 months
Secondary outcomes (2)
Secondary Endpoint
Estimating the rate of:
- Retrieval success
- Device and procedure related adverse events
Measured: 24 months
filter performance rate
Assessing filter performance rate:
- Filter migration
- Filter fracture
- Filter Tilt
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2013 (estimated)
- Primary completionApr 2015 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: IDE was withdrawn. Veniti no longer owns the rights to this device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veniti
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787773
- Sponsor's protocol ID
- FIL-HUM-002P
- Other IDs
- ACTRN12612001255875
- Acronym
- VERITAS
- Status last verified
- Oct 2018
- First submitted
- 6 Feb 2013
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01787773
- Acronym / sponsor ID
- VERITAS / FIL-HUM-002P
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Keywords
- Inferior Vena Cava Filter, Vena Cava Filters
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IDE was withdrawn. Veniti no longer owns the rights to this device.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VenitiIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (estimated)
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 11 Feb 2013 (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 a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients.
Detailed description
Verify the effectiveness and safety of the Veniti IVC Filter in accordance with the clinical guidelines published by the Society for Interventional Radiology (SIR) .
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of:
- Procedure failure (assessed at the end of the implant procedure)
- Subsequent pulmonary embolus
- IVC occlusion
- Filter embolization
Secondary assessments include:
Estimating the rate of:
- Retrieval success
- Device and procedure related adverse events
- Assessing filter performance rate: c1.Filter migration c2.Filter fracture c3.Filter Tilt
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veniti Inferior Vena Cava Filter | Experimental | Device: Veniti Inferior Vena Cava Filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥ 18 years
- Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following:
- Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has:
- Pulmonary embolus
- Iliocaval deep vein thrombosis (DVT)
Key exclusion criteria (19 listed)
- Condition that inhibits radiographic visualization of the IVC
- Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins
- Known IVC transverse diameter at target implant site > 28 mm
- Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter
- Known duplication of IVC or left-sided IVC
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 |
|---|---|---|
| Veniti Inferior Vena Cava Filter | Device | Veniti Inferior Vena Cava Filter |
Primary outcome
Clinical Success
Time frame: 6 months
The endpoint is clinical success (versus failure) at 6 months after implant or 1 month post retrieval, whichever occurs first, based on the definition provided by the SIR guidelines, as the absence of: * Procedure failure (assessed at the end of the implant procedure) * Subsequent pulmonary embolus * IVC occlusion * Filter embolization
2 secondary outcomes
Secondary Endpoint
Time frame: 24 months
filter performance rate
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veniti Inferior Vena Cava Filter in people with Deep Vein Thrombosis and Pulmonary Embolus, run by Veniti at 2 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 15 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: withdrawn, as of the sponsor's last update on 3 Oct 2018. 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 3 Oct 2018.