Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001255875
Ethics application status
Approved
Date submitted
28/11/2012
Date registered
29/11/2012
Date last updated
8/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior vena cava filter system in patients at risk for pulmonary embolism
Scientific title
VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior vena cava filter system in patients at risk for pulmonary embolism
Secondary ID [1] 281595 0
N/A
Universal Trial Number (UTN)
U1111-1137-4248
Trial acronym
VERITAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of pulmonary embolism by inserting an inferior vena cava filter 287876 0
Condition category
Condition code
Blood 288242 288242 0 0
Clotting disorders
Cardiovascular 288250 288250 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of an Inferior Vena Cava Filter involves being given a medicine to make the patient sleepy. The area where the Study Physician will make the puncture (small hole) in the neck will be cleaned with a skin sterilizing liquid. Next the treatment area will be numbed with medicine (similar to Novocain that you get at a dentist). A needle will be used to gain access to the vein and then a small tube with the device inside of it will be moved to the area in the vein where the Study Physician wants the device to be. The Study Physician will then put the device where it is going to stay and pull the small tube out. After the procedure the Study Physician will press on the area of the neck where the needle was until bleeding stops. This procedure will be completed once. The complete procedure will be less than 1 hour in duration. The medication used to numb the area will be different from the medication used to make the patient "sleepy". The protocol does not require specific medications to be used. The choice of the type and amount of medication will be up to the investigator's preference and per local guidelines. The device may be removed as soon as 5 days or may be permanent depending on the participant's condition.
Intervention code [1] 286122 0
Treatment: Devices
Intervention code [2] 286126 0
Prevention
Comparator / control treatment
N/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288432 0
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)
a) Subsequent pulmonary embolus
b) IVC occlusion
c) Filter embolization
Timepoint [1] 288432 0
Follow up for 24 months post implant or 1 month post retrieval whichever comes first
Secondary outcome [1] 300146 0
Secondary assessments include estimating the rate of retrieval success.
Timepoint [1] 300146 0
This will be completed at the time of retrieval if applicable. This is determined by asking the physician post retrieval how they felt the procedure went.
Secondary outcome [2] 300149 0
Assessing filter performance rate:
a) Filter migration
b) Filter fracture
c) Filter Tilt
Timepoint [2] 300149 0
Follow up for 24 months post implant or 1 month post retrieval whichever comes first.
These will be assessed by a venogram during placement, an x-ray, and a CT scan at the 6 month post device placement.
Secondary outcome [3] 300154 0
Secondary assessments include estimating the rate of device and procedure related adverse events
Timepoint [3] 300154 0
Adverse Events are collected throughout the duration of the subject's participation.

Eligibility
Key inclusion criteria
1)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:

2) 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:

2a) Pulmonary embolus
2b) Iliocaval deep vein thrombosis (DVT)
2c) Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures
2d) Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery
2e)Past history of thromboembolic disease undergoing surgery

3) Therapeutic anticoagulation can be achieved, but the patient has:

3a)Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve
3b)Massive pulmonary embolism already treated with thrombectomy or any thrombolytic therapy
3c)Chronic pulmonary embolism already treated with thrombectomy
3d)Large, free floating proximal, e.g., iliofemoral or iliocaval, DVT
3e)Iliocaval DVT with planned catheter thrombectomy or thrombolysis treatment OR
3f)Medical condition with high risk of venous thromboembolism
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential subjects will be excluded from the study if any of the following conditions apply:
1)Condition that inhibits radiographic visualization of the IVC
2)Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins
3)Known IVC transverse diameter at target implant site > 28 mm
4)Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter
5)Known duplication of IVC or left-sided IVC
6)Severe kyphosis or scoliosis
7)Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis
8)Risk for septic pulmonary embolism
9)Confirmed bacteremia
10)Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent.
11)Contrast agent allergy that cannot be adequately pre-medicated
12)Known hypersensitivity to Nitinol (nickel-titanium), platinum, Polyether ether ketone (PEEK), UV Cure Adhesive or Cyanoacrylate Adhesive
13)Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
14) Life expectance < 6 months
15)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.)
16) Has filter in place or underwent filter retrieval in previous 60 days
17) Simultaneously participating in another therapeutic drug or device clinical trial or has participated in such trial in the 30 days prior to enrollment
18) 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
19)Patient does not wish to consent to study or comply with study procedures, including possible 2 year follow up

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential particpants will be patients referred to Radiology for IVC filter placement. The trial option will be presented to the participant. If they qualify and wish to participate they will recieve the Veniti IVC filter. If they do not wish to participate or do not qualify they would recieve an off the shelf approved IVC filter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subjects who wish to participate and who qualify will recieve the Veniti IVC filter.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4693 0
New Zealand
State/province [1] 4693 0
Auckland
Country [2] 4694 0
United States of America
State/province [2] 4694 0

Funding & Sponsors
Funding source category [1] 286402 0
Commercial sector/Industry
Name [1] 286402 0
Veniti
Country [1] 286402 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Veniti
Address
1610 Des Peres Road
Suite 385
Saint Louis, Missouri 63131
Country
United States of America
Secondary sponsor category [1] 285184 0
Commercial sector/Industry
Name [1] 285184 0
Pacific Clinical Research Group
Address [1] 285184 0
Pacific Clinical Research Group (PCRG)
P.O. Box 1600
North Sydney NSW 2059
Australia
Country [1] 285184 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288466 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288466 0
Ethics committee country [1] 288466 0
Australia
Date submitted for ethics approval [1] 288466 0
18/11/2012
Approval date [1] 288466 0
Ethics approval number [1] 288466 0
Ethics committee name [2] 289073 0
Auckland District Health Board
Ethics committee address [2] 289073 0
Research Office
Level 14, Support Bldg
Auckland City Hospital
PB 92024 Grafton, Auckland
Ethics committee country [2] 289073 0
New Zealand
Date submitted for ethics approval [2] 289073 0
Approval date [2] 289073 0
13/02/2013
Ethics approval number [2] 289073 0

Summary
Brief summary
The blockage of the vein leading to the lungs is usually caused by a blood clot coming from the legs. The device is a small metal cage that will be placed in the large vein (inferior vena cava) leading to the heart. The device is placed there to prevent clots from reaching the lungs. The study device is not approved for use in the prevention of reoccurring lung clots. Use of this product is considered investigational in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34989 0
Dr Dr William Kuo
Address 34989 0
300 Pasteur Drive, H-3651
Stanford, CA 94305-5642
Country 34989 0
United States of America
Phone 34989 0
+1 650-723-0728
Fax 34989 0
Email 34989 0
[email protected]
Contact person for public queries
Name 18236 0
Mrs Abigail Fitzhugh
Address 18236 0
1610 Des Peres Road
Suite 385
Saint Louis, Missouri 63131
Country 18236 0
United States of America
Phone 18236 0
+1-314-266-1367
Fax 18236 0
+1-636-628-9991
Email 18236 0
[email protected]
Contact person for scientific queries
Name 9164 0
Mrs Abigail Fitzhugh
Address 9164 0
1610 Des Peres Road
Suite 385
Saint Louis, Missouri 63131
Country 9164 0
United States of America
Phone 9164 0
+1-314-266-1367
Fax 9164 0
+1-636-628-9991
Email 9164 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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