NCT01787773

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Veniti · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolus

Interventions

Type	Name	Description
DEVICE	Veniti Inferior Vena Cava Filter

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-04-01
• Completion: 2017-04-01
• First posted: 2013-02-11
• Last updated: 2018-10-03

Locations

2 sites across 2 countries: Australia, New Zealand