Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Not applicable

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

NCT02728817 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2017-04-12
Last updated
2025-12-02

Condition(s) studied

End-stage Renal Disease

Investigational drug(s) / intervention(s)

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

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * patient under guardianship

Primary outcome measure(s)

  • Primary patency rate of the access — at 12 months

Trial sites (4)

FacilityCityRegionStatus
Polyclinique Notre Dame Draguignan France
Aphm Marseille France
CHU de Nice - Service de chirurgie vasculaire Nice France
Polyclinique Les Fleurs Ollioules France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02728817 on ClinicalTrials.gov ↗ ← All trials in France