New stent shows promise for dialysis patients with blocked fistulas
NCT ID NCT05232760
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small study tested a special stent (SUPERA) in 12 dialysis patients whose arm fistulas had narrowed. The goal was to see if the stent could keep the fistula open longer and reduce the need for repeat procedures. The approach involved reshaping the connection to improve blood flow. Results focused on how many patients had a working fistula without extra treatment at 3 months.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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12 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Apr 2025
- 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.
Who is studied
Hemodialysis patients from clinics with vascular centers
- 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: 1. Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months. 2. Hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic AVF with significant stenosis (lumen diameter \< 2.7mm) 3. Patients with at least one previous endovascular intervention to restore AVF function 4. The target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic AVF 5. The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation) 6. If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion Exclusion Criteria: 1. Patients with AVF stenosis observed and estimated as nonsignificant (lumen diameter \> 2.7mm) or a vessel \<4.0 and \> 7.5 mm in diameter by visual estimation 2. Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated. 3. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device. 4. Patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study. 5. Prior enrolment in this trial 6. Women who are pregnant or lactating 7. Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study. 8. Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -
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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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Klinikum Hochsauerland GmbH
Arnsberg, 59759, Germany
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