NCT02728817

Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation

Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the construction of hemodialysis arteriovenous fistula. In this technique, the radial artery pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of this study is to compare the safety and efficacy of this technique with the traditional end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular access in hemodialysis patients. The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of maturation and patency.

Detailed description

In current nephrology and vascular surgery guidelines, end-cephalic to side-radial arteriovenous fistula is the gold standard for primary vascular access creation. However, these wrist AVFs are recognized to have the worst patency of any autogenous vascular accesses. Outcome improvement is therefore urgent in the field of vascular access, which concerns a growing incident population of patients with end-stage renal disease requiring hemodialysis. Primary AVF failure, including failure to mature, occurs in \~35-40% in just the first year, generally due to juxta-anastomotic stenosis. Many AVF subsequently require additional interventions to mature successfully. The primary patency for these AVFs is poor with 55% at 12 months. Juxta-anastomotic neointimal hyperplasia typically occurs in the swing segment, e.g. the proximal vein mobilized to form the end-to-side anastomosis. This surgically-mobilized segment coincides both with turbulent flow as well as with devascularization of the vasa vasorum. These processes have been associated with endothelial cell activation and a dysfunctional phenotype. Therefore investigators hypothesized that surgical techniques which minimize venous dissection may improve fistula maturation and access patency. Accordingly, investigators developed the "Radial Artery Deviation And Reimplantation (RADAR) technique." Instead of using a traditional end-vein to side-artery anastomosis, RADAR uses an end-artery to side-vein anastomosis, additionally coupled with minimal vessel dissection. Investigators extend conventional "no touch" techniques and advocate avoidance of any venous dissection or manipulation. Investigators minimize arterial dissection as well, by dissecting the radial artery pedicle, not the artery itself. The aim of this study is to compare the safety and efficacy of this novel technique with the traditional radial-cephalic fistula in the setting of a multicenter randomized controlled trial. Besides traditional endpoints such as patency and reintervention rates, hand blood perfusion will be assessed with objective measurements.

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
PROCEDURE	End-cephalic vein to side-radial artery fistula creation	* Circumferential dissection of the cephalic vein (4-5cm long) * Longitudinal arteriotomy (\~10mm) * End-vein to side-artery anastomosis using 7-0 polypropylene continuous suture
PROCEDURE	RADAR fistula creation	* Dissection of the anterior-medial aspect of the cephalic vein (\~15mm) without grasping or clamping the venous wall * Circumferential dissection of the radial artery pedicle (5cm long) and ligation of collaterals with surgical microclips * Ligation and section of the radial artery (distal) * Longitudinal venotomy (\~10mm) * End-artery to side-vein anastomosis using 7-0 polypropylene continuous suture

Timeline

• Start date: 2017-04-12
• Primary completion: 2018-04-12
• Completion: 2026-09-09
• First posted: 2016-04-05
• Last updated: 2025-12-02

Locations

4 sites across 1 country: France