NIHR Clinical Research Network Adopts Spiral Flow™ AV Graft Randomised Controlled Trial
10/05/2015

Vascular Flow Technologies announces adoption of its randomised controlled trial of the Spiral Flow™ AV graft for use in ERSD by the NIHR CRN.

Online PR News – 05-October-2015 – Dundee, UK – Vascular Flow Technologies, the medical device company using proprietary Spiral Laminar Flow™ (SLF™) technology to replicate natural blood flow for enhanced patient outcomes, today announces the adoption of its randomised controlled trial (RCT) of the Spiral Flow™ AV graft for use in arteriovenous haemodialysis access in end-stage renal disease (ERSD) by the National Institute of Health Research Clinical Research Network (NIHR CRN).

The Spiral Flow™ haemodialysis access study will recruit 189 patients to investigate real world clinical and economic outcomes of the Spiral Flow™ AV graft when used to gain arteriovenous access for haemodialysis in patients with ESRD.

The CRN is part of the NIHR, established by the Department of Health to integrate world-leading research into the NHS. Adoption of the study by the CRN will provide a support infrastructure for the clinical trials, including funding to cover equipment costs and use of facilities, funding and training for staff to provide logistical support, and a streamlined system to enable the efficient set-up of trials at new sites. In addition, the CRN provides advice on suitable new NHS sites with the facilities and patient populations required.

Spiral Flow™ grafts use VFT’s proprietary Spiral Laminar Flow™ (SLF) Technology, proven to induce natural blood flow with the use of a patented helical groove1,2. By replicating the blood’s natural flow pattern, Spiral Flow™ grafts reduce turbulence and blood flow stagnation3. These disturbances in blood flow are risk factors for thrombosis, a major cause of failure in AV access grafts4.

A randomised controlled trial of the Spiral Flow™ AV graft is currently underway at St. Georges Hospital, London, UK, where the first patient has been enrolled.

Bill Allan, CEO of VFT commented, ‘NIHR supporting the study means CRN’s infrastructure will allow easier enrolment of patients and addition of new satellite sites, allowing us to complete the study on schedule and add to the considerable body of evidence on VFT’s SLF™ technology.”

References:

1. Stonebridge PA, Buckley C, Thompson A, Dick J, Hunter G, Chudek JA, Houston JG, Belch JJ. Non spiral and spiral (helical) flow patterns in stenosis. In vitro observations using spin and gradient echo magnetic resonance imaging (MRI) and computational fluid dynamic modelling. In Angiol 2004 Sep;23(3):276-83.
2. Kokkalis E, Hoskins P, Corner G, Stonebridge P, Doull A, Houston G. Secondary flow in peripheral vascular prosthetic grafts using vector Doppler imaging. Ultrasound in Med & Biol 2013;39(12):2295-2307.
3. El Sayed HF. Vascular Flow Technology: Another run of the mill graft or a breakthrough technology? US experience and perspective. Presented at the 8th International St George’s Vascular Access Meeting at the 35th Charing Cross international vascular and endovascular symposium, 7th April 2013, London.
4. Hodges TC, et al. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg 1997;26:1009-1019.