New balloon could cut hospital stays for dialysis patients
NCT ID NCT02408822
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a drug-coated balloon to a standard balloon for treating narrowed blood vessels in dialysis patients. The drug-coated balloon releases paclitaxel to help prevent the vessel from narrowing again. The goal is to see if it keeps the access working longer and reduces the need for repeat procedures and hospital stays.
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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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52 people
The number who actually took part.
- Started
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Sep 2015
- Expected to finish
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Jun 2026
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: * Patient must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. * Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) * Patient must have a dysfunction of its vascular access, defined by : * dialysis sessions last \>4 hours * and/or access flow \< 400ml/min for fistulae and \<600ml for grafts, or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan, * and/or dialysis recirculation * and/or thrill not perceived * and/or pulsatile vascular access * and/or bleeding or increased bleeding time after puncture * A stenosis \>50% of the venous line must be diagnosed on the initial fistulogram * A successful plain balloon angioplasty of the stenosis, defined by residual stenosis \<30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion. Exclusion Criteria: * Pregnant or nursing woman, or plans to become pregnant during the study. * Patient has hyperkalemia \>6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion * Vascular access has in-stent restenosis * Initial fistulogram shows no stenosis * Initial fistulogram shows indication for open surgical intervention * Control fistulogram (after plain balloon angioplasty) shows indication for stenting or open surgical intervention
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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.
Contacts and locations
Locations
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CHU de Nice - Service de chirurgie vasculaire
Nice, France
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CHU de Reims
Reims, France
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Clinique St Georges
Nice, France