VERTO, Revision A
Research type
Research Study
Full title
Retrospective Evaluation of the Safety and Effectiveness of Deploying the VENITI® VICI VENOUS STENT® from the VERTO Delivery System in Non-Thrombotic and Post-Thrombotic Disease in the Venous Tract
IRAS ID
244329
Contact name
Stephen Black
Contact email
Sponsor organisation
Veniti, Inc.
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
The VERTO study is a retrospective data collection study which plans to include approximately 30 patients who have previously been treated with a commercially available device, the VICI VENOUS STENT, using the VERTO delivery system for non-thrombotic or post-thrombotic disease (blood clotting disease) in the venous system (the body system that transports blood from the arms and legs to the heart). Safety, procedure and clinical follow up data will be collected from patients’ medical records from the day of procedure through 30 days (-7/+14 days) after. The study aims to obtain real world data to include in a marketing application to US authorities so the same device may be made commercially available to patients in the US.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0110
Date of REC Opinion
5 Apr 2018
REC opinion
Favourable Opinion