NCT06708338Recruiting
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis: A Multicenter Randomized Comparative Study
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
End-stage renal disease (ESRD) is a condition in which the filtration function of the kidneys has deteriorated, necessitating dialysis or transplantation. With an aging population, the number of patients undergoing dialysis for CKD is constantly increasing. There are different types of dialysis treatment: hemodialysis and peritoneal dialysis. Hemodialysis involves exchanges between blood and a dialysate (a liquid used to purify blood) via a dialyzer (artificial filter), coordinated by a generator. This method requires a vascular approach, of which there are 3 types: the arteriovenous fistula (AVF), the arteriovenous graft and the central venous catheter. The AVF remains the vascular access of choice for hemodialysis sessions, and its preservation is an essential objective for patients with CKD. One of the major challenges for AVFs is to achieve a successful puncture, an act performed around 310 times a year per patient, for dialysis performed three times a week with double needles. This repeated procedure can cause damage to the AVF, leading to complications such as stenosis, thrombosis, aneurysm, superficial infection, hematoma, bleeding, parietal rupture or dissection. However, there is no official recommendation on the most conservative puncture technique for AVF. In view of the number of patients concerned and the recurrence of puncture, it would seem essential to evaluate the impact of bevel orientation on the occurrence of complications during dialysis by means of a randomized prospective study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 7 Jan 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Centre Hospitalier Emile Roux
- Diseases
- Chronic kidney disease
- NCT number
- NCT06708338
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 7 Jan 2026 to the primary completion date, 30 Jun 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned transplant within the next 12 months
- Previous AVF creation, except for the fistula of interest
Other illness
- Patient with a history of cancer within the past 5 years or active cancer
- Patient with psychiatric pathologies or cognitive disorders
Other
- Auto-dialysis at home
- Puncture using the buttonhole technique
- Patient requiring AVF puncture with a catheter
- Patient under court protection or guardianship
- Pregnant and breast-feeding women
- Patient follow-up difficult or impossible for geographical or other reasons, at the investigator's discretion
Who the study is looking for
- male or female with Chronic Kidney Disease
- patient requiring 4-hour hemodialysis sessions, 3 times per week, in a dialysis center
- Native arteriovenous fistula (AVF) (without prosthesis), mature, with no prior puncture, located in the upper limb
- First fistula for a hemodialysis patient
- Expected duration of dialysis ≥ 1 year
- Double-needle dialysis
- Hemodialysis possible on AVF
- Average AVF flow rate between 500 and 2,000 mL/min
- Affiliated with a social security scheme
- Free and informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Emile Roux Coordinator of this site? Confirm its status | Le Puy-en-Velay | France | Recruiting |
| Hôpital Saint Joseph Saint Luc Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier de Moulins-Yzeure Coordinator of this site? Confirm its status | Moulins | France | Not yet recruiting |
| Ctre Hospitalier Intercommunal Poissy St Germain Site Poissy Coordinator of this site? Confirm its status | Poissy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.