Clinical trial NCT02728817: Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation
Official title: Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Vascular access
Hemodialysis
Arteriovenous fistula
Stenosis
Failure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary patency rate of the access
timeFrame: at 12 months
Secondary outcomes:
measure: Assisted primary patency rate of the access
timeFrame: 6 & 12 months
Other outcomes:
Locations:
city: Draguignan
country: France
facility: Polyclinique Notre Dame
city: Marseille
country: France
facility: Aphm
city: Nice
country: France
facility: CHU de Nice - Service de chirurgie vasculaire
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
Study officials:
affiliation: Vascular surgery, Nice University Hospital
name: Serge DECLEMY, MD
role: PRINCIPAL_INVESTIGATOR
References: