Vascular Flow Technologies has announced the start of a randomised controlled clinical trial at St Georges Hospital, London, UK.
The 189-patient trial is using current best practice as the comparator, and is designed to test the hypothesis that restoring the natural spiral blood flow pattern will increase arteriovenous graft patency in patients undergoing haemodialysis, resulting in fewer interventions over a 24-month period.
The trial will assess graft patency measured as the interval between graft placement and access thrombosis, or interventions to maintain, assist or re-establish patency over the 24-month period. In addition, this clinical measurement the trial will record the costs of interventions, producing data to support health economic evaluation of the Spiral Flow AV Graft.
Spiral Laminar Flow technology has been available since 2008 and is proven to replicate natural blood flow by generating a spiral laminar flow within the graft, reducing turbulence at the point where the blood flows into the blood vessel. This limits changes to the blood vessel wall that may be precursors to thrombosis. The clinical effectiveness of this technology has been reported in a number of published studies, with high patency rates at 30 months in vascular reconstruction in the leg (81% above the knee and 57–64% below the knee).
The trial will involve patients with end stage renal disease requiring dialysis, who will be randomised to Spiral Flow AV Graft or a standard polytetrafluoroethylene (PTFE) bridge graft. The main complication for PTFE grafts used for haemodialysis is thrombosis, which is reported to contribute to 70% of failures and these grafts show patency rates in published literature of 41–68% at one year, and 25% at two years.
Eric Chemla, consultant vascular surgeon, St George’s Hospital, London, UK and lead investigator for the study commented: “St George’s Hospital has one of the largest dialysis units in the UK, with a team of experienced vascular access surgeons, and a high throughput of this type of procedure. We are excited to be the trial centre for this study, which will produce clinical and economic evidence on the utility of this potentially game-changing technology.”
The haemodialysis access study is supported in part by a Scottish Enterprise Grant awarded to Dundee-based Vascular Flow, which is are gathering evidence to support wider applications of their proprietary Spiral Flow technology.
Bill Allan, chief executive officer of Vascular Flow said: “We are truly delighted to announce the first patient into this trial. We are confident in our technology and are now pursuing trials that will consolidate the clinical evidence gained to date, and provide data for health economic appraisals.”