VALUE VasQ PMS
Research type
Research Study
Full title
VALUE- Vascular Access Laminate eUropean Experience A post market surveillance multi-center prospective study to evaluate the safety and efficacy of the VasQ external support for arteriovenous fistula
IRAS ID
247019
Contact name
Daniella Bleistein
Contact email
Sponsor organisation
Laminate Medical Technologies Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Is the VasQ device safe and effective in improving the function of arteriovenous fistulas performed for vascular access in end stage renal diseases patients?
Surgical formation of an Arterio-Venous (AV) fistula is well established as the procedure of preference for access to blood vessels in patients with chronic kidney disease requiring haemodialysis treatment. However, up to 40% of the fistulas fail to mature and cannot be used for dialysis. The VasQ device, a delicate sleeve threaded over the fistula during the surgical procedure, provides external support to the connected artery and vein. It is designed to take load off the vein and regulate the blood flow patterns, which has the potential of improving fistula maturation. The aim of the study is to determine if using the VasQ device around the fistula will be beneficial in maintaining the fistula open for blood flow and adequate for access over time. The device is already approved for market in Europe, however since it is new, not enough evidence exists and this is the reason for performing this study. Patients with chronic kidney disease requiring surgical formation of AV fistula in order to enable haemodialysis treatment are invited to take part in this study. A total of 80 patients in up to 12 hospitals in Germany, UK, and Spain will be recruited. All study participants will have the VasQ device implanted over their fistula. Participants will be followed for 12 months, during which they will be required to arrive for follow-up visits at 1, 3, 6, and 12 months after surgery. A phone-call will be conducted at 9 months after surgery. During the follow-up visits, the fistula will be examined with a Doppler ultrasound, a routine method for testing blood flow through the fistula. The study is funded by Laminate Medical Technologies, manufacture of the VasQ device.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1050
Date of REC Opinion
20 Aug 2018
REC opinion
Further Information Favourable Opinion