End-stage Renal DiseaseRADARNCT02728817
Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation
A study testing End-cephalic vein to side-radial artery fistula creation and RADAR fistula creation in people with End-stage Renal Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- End-cephalic vein to side-radial artery fistula creation and RADAR fistula creation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Apr 2017to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- patient under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Polyclinique Notre Dame
Draguignan
Aphm
Marseille
CHU de Nice - Service de chirurgie vasculaire
Nice
Polyclinique Les Fleurs
Ollioules
About this study
Official title: Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- End-cephalic vein to side-radial artery fistula creation, RADAR fistula creation
- Keywords
- Vascular access, Hemodialysis, Arteriovenous fistula, Stenosis, Failure
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-cephalic vein to side-radial artery fistula creationProcedure or surgery
- 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 creationProcedure or surgery
- 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 group | Role | What they receive |
|---|---|---|
| arteriovenous fistula (AVF) | Active comparator | Patient receiving a traditional arteriovenous fistula at the wrist (end-cephalic vein to side-radial artery) Receives: 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) Receives: Procedure: RADAR fistula creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate of the access
Measured: at 12 months
Secondary outcomes (1)
Assisted primary patency rate of the access
Measured: 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start12 Apr 2017
- Primary completion12 Apr 2018
- Study completion9 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge DECLEMY, MD, Principal investigator, Vascular surgery, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728817
- Sponsor's protocol ID
- 15-API-02
- Acronym
- RADAR
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2016
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02728817
- Acronym / sponsor ID
- RADAR / 15-API-02
- Conditions
- End-stage Renal Disease
- Keywords
- Vascular access, Hemodialysis, Arteriovenous fistula, Stenosis, Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arteriovenous fistula (AVF) | Active comparator | Procedure: End-cephalic vein to side-radial artery fistula creationPatient receiving a traditional arteriovenous fistula at the wrist (end-cephalic vein to side-radial artery) |
| RADAR | Experimental | Procedure: RADAR fistula creationPatient receiving an arteriovenous fistula at the wrist using the Radial Artery Deviation And Reimplantation technique (end-radial artery to side-cephalic vein) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient referred by the nephrologist for the creation of a primary vascular access
- Clinical examination of both upper limbs showing on the same limb:
- Preoperative arterial and venous duplex ultrasound examination of both limbs showing on the same limb :
- Digital pressure >50mmHg when occlusive compression is made on the radial artery and digital/brachial ratio >0.5
Key exclusion criteria (1 listed)
- patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | arteriovenous fistula (AVF) |
| 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 | Procedure or surgery | RADAR |
Primary outcome
Primary patency rate of the access
Time frame: at 12 months
1 secondary outcome
Assisted primary patency rate of the access
Time frame: 6 & 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for End-stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge DECLEMY, MD principal investigator
Vascular surgery, Nice University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-cephalic vein to side-radial artery fistula creation and RADAR fistula creation in people with End-stage Renal Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate of the access (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.