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VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction

NCT02112877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-15

Study results available
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Summary

This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

Conditions

  • Chronic Venous Disorder
  • Venous Outflow Obstruction
  • Symptomatic Venous Outflow Obstruction of Iliofemoral Vein

Interventions

DEVICE

Veniti Vici™ Venous Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • William Marston, MD · UNC Department of Surgery

  • Mahmood Razavi, MD · Vascular and Interventional Specialists of Orange County

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-26
Primary Completion
2017-12-05
Completion
2020-12-18
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112877 on ClinicalTrials.gov