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

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ClinicalTrials.gov Identifier: NCT02728817
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
End-stage Renal Disease Procedure: End-cephalic vein to side-radial artery fistula creation Procedure: RADAR fistula creation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : April 12, 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Active Comparator: arteriovenous fistula (AVF)
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
  • Circumferential dissection of the cephalic vein (4-5cm long)
  • Longitudinal arteriotomy (~10mm)
  • End-vein to side-artery anastomosis using 7-0 polypropylene continuous suture

Experimental: RADAR
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
  • 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




Primary Outcome Measures :
  1. Primary patency rate of the access [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Assisted primary patency rate of the access [ Time Frame: 6 & 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728817


Contacts
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Contact: Nirvana SADAGHIANLOO, MD +33492033835 sadaghianloo.n@chu-nice.fr

Locations
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France
CHU de Nice - Service de chirurgie vasculaire Recruiting
Nice, France
Contact: Nirvana Sadaghianloo, MD    04 92 03 38 35    sadaghianloo.n@chu-nice.fr   
Principal Investigator: Serge DECLEMY         
Sub-Investigator: Nirvana SADAGHIANLOO         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Serge DECLEMY, MD Vascular surgery, Nice University Hospital
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02728817    
Other Study ID Numbers: 15-API-02
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
Vascular access
Hemodialysis
Arteriovenous fistula
Stenosis
Failure
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency