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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01787773




Registration number
NCT01787773
Ethics application status
Date submitted
6/02/2013
Date registered
11/02/2013
Date last updated
3/10/2018

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] 0 0
ACTRN12612001255875
Secondary ID [2] 0 0
FIL-HUM-002P
Universal Trial Number (UTN)
Trial acronym
VERITAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis 0 0
Pulmonary Embolus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Veniti Inferior Vena Cava Filter -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Success
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Secondary Endpoint
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
filter performance rate
Timepoint [2] 0 0
24 months

Eligibility
Key inclusion criteria
* = 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2017
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Veniti
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients.
Trial website
https://clinicaltrials.gov/study/NCT01787773
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01787773