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

NCT02728817 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • End-stage Renal Disease

Interventions

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Serge DECLEMY, MD · Vascular surgery, Nice University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2018-04-12
Completion
2026-09-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728817 on ClinicalTrials.gov