VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01787773
Study type	Interventional
Source	Veniti
Contact
Status	Withdrawn
Phase	N/A
Start date	March 2013
Completion date	April 2017

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms