VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Veniti
ClinicalTrials.gov Identifier:
NCT01787773
First received: February 6, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Deep Vein Thrombosis
Pulmonary Embolus
Device: Veniti Inferior Vena Cava Filter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Veniti:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Secondary Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    Estimating the rate of:

    • Retrieval success
    • Device and procedure related adverse events

  • filter performance rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    Assessing filter performance rate:

    • Filter migration
    • Filter fracture
    • Filter Tilt


Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veniti Inferior Vena Cava Filter Device: Veniti Inferior Vena Cava Filter

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:

  1. Procedure failure (assessed at the end of the implant procedure)
  2. Subsequent pulmonary embolus
  3. IVC occlusion
  4. Filter embolization

Secondary assessments include:

Estimating the rate of:

  1. Retrieval success
  2. Device and procedure related adverse events
  3. Assessing filter performance rate:

c1.Filter migration c2.Filter fracture c3.Filter Tilt

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787773

Locations
Australia
Alfred Hospital
Melbourne, Australia, 3004
New Zealand
Auckland City Hospital
Grafton, New Zealand, 1142
Sponsors and Collaborators
Veniti
  More Information

No publications provided

Responsible Party: Veniti
ClinicalTrials.gov Identifier: NCT01787773     History of Changes
Other Study ID Numbers: FIL-HUM-002P, ACTRN12612001255875
Study First Received: February 6, 2013
Last Updated: June 26, 2014
Health Authority: New Zealand: Ministry of Health

Keywords provided by Veniti:
Inferior Vena Cava Filter
Vena Cava Filters

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014