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

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.

Study Overview

• Status: Withdrawn
• Conditions: Deep Vein Thrombosis; Pulmonary Embolus
• Intervention / Treatment: 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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • Alfred Hospital
• New Zealand
  • Grafton, New Zealand, 1142
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Veniti Inferior Vena Cava Filter	Device: Veniti Inferior Vena Cava Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	Estimating the rate of: Retrieval success; Device and procedure related adverse events	24 months
filter performance rate	Assessing filter performance rate: Filter migration; Filter fracture; Filter Tilt	24 months

Collaborators and Investigators

• Sponsor: Veniti

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): April 1, 2017

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (ESTIMATE): February 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Inferior Vena Cava Filter; Vena Cava Filters
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: FIL-HUM-002P; ACTRN12612001255875 (OTHER: Australian New Zealand Clinical Trials Registry)