VIRTUS – OUS
Research type
Research Study
Full title
Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti Inc.) when Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment Subtitle: A Study Looking at the Veniti Vici™ Venous Stent System (Veniti Inc.) to Treat Patients with Symptoms of Long-standing, Non-Cancerous Blockage(s) of a Major Vein in the Leg
IRAS ID
147449
Contact name
Stephen Black
Contact email
Sponsor organisation
Boston Scientific Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 3 months, 31 days
Research summary
Veniti, Inc., the sponsor of this study, has developed the Veniti Vici™ Venous Stent System to treat patients with restricted blood flow through the iliofemoral vein (a vein in the leg). The device that will be used in the study is a small metal tube called a stent which will be placed in the iliofemoral vein by the study doctor to try to reduce the restriction.
This device is CE Marked meaning that it is approved for commercial use throughout Europe for the treatment of restricted blood flow through the iliofemoral vein. Veniti is conducting this study to evaluate the performance and safety of the system by recording any signs of complications or unwanted side effects. There will be approximately 200 patients in this study across many countries, including locations around the world. Information will be collected before, during and immediately after the procedure and for a period of 36 months (3 years) following the procedure.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/0115
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion