New surgical trick could make dialysis access last longer
NCT ID NCT06997042
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two ways to create an arteriovenous fistula (AVF) for dialysis in people with advanced kidney disease. The standard end-to-side method is being tested against a newer piggyback technique that may reduce blockages and failures. About 130 adults who need dialysis will be randomly assigned to one of the two procedures and followed for a year to see which works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical procedure (arteriovenous fistula creation technique)
- What this could lead to
- If one technique proves better, it could mean fewer failed fistulas and smoother dialysis access for kidney patients.
- What could go wrong
- This is a small, early-stage trial comparing surgical methods, so results may not apply broadly. Both techniques carry standard surgical risks like infection or clotting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \> 18 years * Able to meet protocol requirements, including follow-up. * Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D). * In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on standard clinical criteria). * Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance procedures. * Have a current ultrasound with preoperative venous and arterial mapping. * Meet the anatomical requirements for AVF creation: * Wrist: artery \>2 mm, vein \>2 mm in diameter * Elbow: artery \>3 mm, vein \>3 mm in diameter * Absence of arterial calcification or occlusion, or other aberrant arterial anatomy. * Adequate arterial and venous patency. * Vein-to-skin distance \<5 mm. * Candidate for creation of a native arteriovenous fistula for hemodialysis, either distal (radiocephalic) or proximal (humerocephalic or humerobasilic). * No immediate transplant scheduled within the next 60 days (inclusion on the kidney transplant waiting list is not a contraindication for entry into the study, nor for the creation of an arteriovenous fistula). * No prior arteriovenous surgeries in the same or proximal location. * Correct understanding of the study conditions and acceptance to participate. Exclusion Criteria: * Pregnant women. * Life expectancy \<1 year. * Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and unusual (exotic) accesses. * Known or suspected central venous stenosis/occlusion on the side of the planned access. * Repair of previous arteriovenous accesses (proximal reanastomoses). * Biological immunosuppression. * History or evidence of serious systemic illness, including: * Cardiac disease (New York Heart Association functional class III or IV, as evidenced by the inability to lie still), myocardial infarction within 6 weeks prior to randomization, ventricular tachyarrhythmia requiring ongoing treatment, or unstable angina. Suspected or documented hypercoagulable or hypocoagulable state or Clinically significant active infection (White blood count \> 15,000 cells/mm3) other than the use of a treated CVC. * Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and efficacy of the study or poor compliance. * Patient unwilling or unable to attend follow-up follow-ups.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clínic de Barcelona
RECRUITINGBarcelona, Barcelona, 08018, Spain
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