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

NCT02728817 | Active Not Recruiting

• 1 other identifier: 15-API-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Vascular access; Hemodialysis; Arteriovenous fistula; Stenosis; Failure

Outcome Measures

Primary Outcomes (1)

• Primary patency rate of the access

  at 12 months

Secondary Outcomes (1)

• Assisted primary patency rate of the access

  6 & 12 months

Study Arms (2)

arteriovenous fistula (AVF)

ACTIVE COMPARATOR

Patient receiving a traditional arteriovenous fistula at the wrist (end-cephalic vein to side-radial artery)

Procedure: End-cephalic vein to side-radial artery fistula creation

RADAR

EXPERIMENTAL

Patient receiving an arteriovenous fistula at the wrist using the Radial Artery Deviation And Reimplantation technique (end-radial artery to side-cephalic vein)

Procedure: RADAR fistula creation

Interventions

End-cephalic vein to side-radial artery fistula creation PROCEDURE

* Circumferential dissection of the cephalic vein (4-5cm long) * Longitudinal arteriotomy (\~10mm) * End-vein to side-artery anastomosis using 7-0 polypropylene continuous suture

arteriovenous fistula (AVF)

RADAR fistula creation PROCEDURE

* 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

RADAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred by the nephrologist for the creation of a primary vascular access
• Clinical examination of both upper limbs showing on the same limb:
• A cephalic vein at the distal third of the forearm
• Radial pulse
• Ulnar pulse
• Positive Allen test (patent palmar arches)
• Preoperative arterial and venous duplex ultrasound examination of both limbs showing on the same limb :
• A patent cephalic vein, ≥2mm in diameter at the distal 1/3 of the forearm, free from stenosis, ≥15cm in length
• A patent on dominant radial artery, ≥2mm in diameter at the distal 1/3 of the forearm, free from stenosis and major calcifications
• A patent ulnar artery, free from stenosis and major calcifications
• A positive Allen's test with assessment of the retrograde flow (patent palmar aches)
• Digital pressure \>50mmHg when occlusive compression is made on the radial artery and digital/brachial ratio \>0.5

You may not qualify if:

• patient under guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

Polyclinique Notre Dame

Draguignan, France

Location

Aphm

Marseille, France

Location

CHU de Nice - Service de chirurgie vasculaire

Nice, France

Location

Polyclinique Les Fleurs

Ollioules, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Serge DECLEMY, MD

  Vascular surgery, Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 5, 2016
• Study Start: April 12, 2017
• Primary Completion: April 12, 2018
• Study Completion (Estimated): September 9, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)