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

NCT01787773 | Withdrawn

• 2 other identifiers: FIL-HUM-002PACTRN12612001255875
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolus

Keywords

Inferior Vena Cava Filter; Vena Cava Filters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Secondary Endpoint

  24 months

• filter performance rate

  24 months

Study Arms (1)

Veniti Inferior Vena Cava Filter

EXPERIMENTAL

Device: Veniti Inferior Vena Cava Filter

Interventions

Veniti Inferior Vena Cava Filter DEVICE

Veniti Inferior Vena Cava Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Veniti: lead

Study Sites (2)

Alfred Hospital

Melbourne, 3004, Australia

Location

Auckland City Hospital

Grafton, 1142, New Zealand

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 11, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

NZ (1); AU (1)