The Spiral Flow Study
Research type
Research Study
Full title
A Multicentre, Randomised, Controlled, Single Blind Clinical Evaluation of the Spiral Flow AV Graft for Arteriovenous Haemodialysis Access in the End Stage Renal Disease Recipient
IRAS ID
156704
Contact name
Eric Chemla
Contact email
Sponsor organisation
St. George's Joint Research and Enterprise Office (JREO
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
A significant proportion of prosthetic grafts used to facilitate haemodialysis fail due to blockages. The primary cause of failure is cell tissue growth called neointimal hyperplasia (NIH). NIH is caused, in large part, by turbulent blood flow that damages the cell lining of the patient's blood vessel near the area where the graft and blood vessel are sown together. Cell tissue growth is the response to this damage and can result in blockage. Spiral Flow grafts are designed to recreate the blood's natural spiral flow pattern, eliminate turbulence and reduce graft blockages. Initial data suggests that Spiral Flow grafts remain unblocked more than conventional grafts. The objective of this investigation is to collect data supporting the performance of the Spiral Flow AV Graft Prosthesis used as an arteriovenous haemodialysis access graft.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1954
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion