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

Veniti

Status

Withdrawn

Conditions

Deep Vein Thrombosis

Pulmonary Embolus

Treatments

Device: Veniti Inferior Vena Cava Filter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01787773

ACTRN12612001255875 (Other Identifier)

FIL-HUM-002P

Details and patient eligibility

About

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.

Full 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:

Procedure failure (assessed at the end of the implant procedure) Subsequent pulmonary embolus IVC occlusion Filter embolization

Secondary assessments include:

Estimating the rate of:

Retrieval success Device and procedure related adverse events Assessing filter performance rate:

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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