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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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
- Primary patency rate of the access [ Time Frame: at 12 months ]
- Assisted primary patency rate of the access [ Time Frame: 6 & 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728817
|Contact: Nirvana SADAGHIANLOO, MDfirstname.lastname@example.org|
|CHU de Nice - Service de chirurgie vasculaire||Recruiting|
|Contact: Nirvana Sadaghianloo, MD 04 92 03 38 35 email@example.com|
|Principal Investigator: Serge DECLEMY|
|Sub-Investigator: Nirvana SADAGHIANLOO|
|Principal Investigator:||Serge DECLEMY, MD||Vascular surgery, Nice University Hospital|