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ACTIVE NOT RECRUITING
NCT02728817
NA

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2017-04-12

Completion Date

2026-09-09

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

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

Locations (4)

Polyclinique Notre Dame

Draguignan, France

Aphm

Marseille, France

CHU de Nice - Service de chirurgie vasculaire

Nice, France

Polyclinique Les Fleurs

Ollioules, France