VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
Completed · Not applicable
Conditions studied: Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
In brief
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.
Key facts
- Study ID
- NCT02112877
- Run by
- Boston Scientific Corporation
- People needed
- 200
- Starts
- 2014-06-26
- Expected to finish
- 2020-12-18
- Last updated by the study team
- 2021-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States
- Healthfinity PLCC — Scottsdale, Arizona, United States
- Arkansas Site Management Services, LLC — Little Rock, Arkansas, United States
- St. Joseph Hospital — Orange, California, United States
- Radiology Imaging Associates — Englewood, Colorado, United States
- Vascular Breakthroughs — Darien, Connecticut, United States
- Midwest Cardiovascular Foundation — Davenport, Iowa, United States
- Imperial Health, LLP — Lake Charles, Louisiana, United States
- Michigan Vascular Center — Flint, Michigan, United States
- NYU School of Medicine — New York, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- New York Presbyterian Hospital/Cornell University — New York, New York, United States
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Dr. Ediberto Soto-Cora — El Paso, Texas, United States
- Sentara Vascular Specialists — Norfolk, Virginia, United States
- University of Washington Medical Center — Seattle, Washington, United States
- Infermerierie Protestante de Lyon — Décines-Charpieu, France
- Hôpital Nord de Marseille — Marsaille, France
- Klinikum Arnsberg, Karolinen Hospital — Arnsberg, Germany
- University Hospital Galway — Galway, Ireland
- Rijnstate Ziekenhuis — Arnhem, Netherlands
- University Hospital HM Monteprincipe — Madrid, Spain
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
- University College London — London, United Kingdom
Full record on ClinicalTrials.gov
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