Medical device firm Vascular Flow Technologies has partnered with Society for Vascular Surgery Patient Safety Organization (SVS PSO) to carry out a new post market observational registry of Spiral Flow arteriovenous (AV) graft for use in haemodialysis access.
SVS PSO will conduct new observational registry for Spiral Flow AV grafts, as part of the Vascular Quality Initiative (VQI).
The Spiral flow Technology AV Access Registry (STAAR) will enrol up to 75 patients with end stage renal disease (ESRD) who require synthetic graft placement for haemodialysis access.
The patients are being recruited at 15 participating centers and will be followed for a period of up to 12 months following graft implantation.
Vascular Flow Technologies chief clinical officer Dr Barbara Bunger said: "The STAAR post market registry will collect intraoperative and acute post-operative outcomes in addition to long term graft performance in real world clinical practice as patients undergo routine dialysis."
The SVS PSO will assess the long-term safety, efficacy and cost effectiveness of Spiral Laminar Flow AV graft, when used as the primary access for patients with ESRD requiring routine haemodialysis.
The implanted Spiral Flow AV graft will be evaluated for primary patency (intervention free access survival), assisted primary patency (thrombosis-free access survival) and secondary patency (access survival until abandonment).