U Clips for arteriovenous anastomosis: a pilot, randomized study

Abstract

The objective of this study was to assess a novel, new, nitinol clip for performing arteriovenous anastomoses. This was a pilot, randomized, blinded trial. The trial was register with Clinicaltrials.gov identifier - NCT00829153. Thirty-one patients undergoing autologous arteriovenous fistulas for renal access, where the inflow artery had a lumen diameter of 2 mm or more and the outflow vein had a diameter of 3 mm or more, were included in this study. At the time of operative preparation and exposure of the vessels, the patients were randomized to a conventional anastomosis with 6/0 Prolene or to U Clip anastomosis. The primary outcome measure was three successful dialysis treatments using the fistula. The primary outcome was achieved in 8/19 (42%) of the Prolene group and 7/12 (58%) in the U Clip group (P = 0.379 chi-squared test Pearson uncorrected). This pilot study has shown no advantage to the U Clip anastomotic technique when compared with the traditional continuous Prolene technique.