Stenosis of Arteriovenous Dialysis FistulaNCT05232760
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
An observational study of Stenosis of Arteriovenous Dialysis Fistula, run by Klinikum Arnsberg at 1 site in Germany.
Trial summary
The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis of Arteriovenous Dialysis Fistula
- What is being tested?
- Supera™ Peripheral Stent System
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2022to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Hemodialysis patients from clinics with vascular centers
Who may be able to join
- Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy > 12 months.
- 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)
- Patients with at least one previous endovascular intervention to restore AVF function
- 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
- The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
- If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion
Who cannot join
- 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
- Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
- Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
- 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.
- Prior enrolment in this trial
- Women who are pregnant or lactating
- Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
- Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.
Read the detailed description
Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.
- Being tested
- Supera™ Peripheral Stent System
- Keywords
- Juxta-anastomotic stenose of arteriovenous fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supera™ Peripheral Stent SystemDevice
The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures
| Study group | Role | What they receive |
|---|---|---|
| SUPERA peripheral stent system | Not described Receives: Device: Supera™ Peripheral Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with primary patency of juxta-anastomose at month 3
Primary patency is defined as clinically assessed intervention free (IFP) period
Measured: 3 months
Secondary outcomes (10)
Number of patients with primary patency of juxta-anastomose
Primary patency is defined as clinically assessed intervention free (IFP) period
Measured: 1, 6 and 12 months.
Number of patients with assisted primary patency
Assisted primary patency is defined as interval until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access
Measured: 1, 3, 6 and 12 months
Number of patients with secondary patency
Secondary patency is defined as interval until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access
Measured: 1, 3, 6 and 12 months
Number of patients with technical success
Residual stenosis < 30% after treatment with Supera stent (measured by angiography during the procedure)
Measured: Day 1 after the index procedure
Number of patients with procedural success
Residual stenosis < 30% with no major adverse events (MAE)
Measured: 1 day (discharge)
Number of patients with clinical success
Hemodialysis access function improved, dialysis function restored, and at least one dialysis session completed after the procedure until discharge
Measured: 1 day (discharge)
Number of patients with access circuit patency
Freedom from development of a stenosis in any region of the AVF circuit, including the juxta-anastomotic segment
Measured: 1,3,6,12 months
Recirculation rate
Measured: 1, 3, 6 and 12 months
Fistula flow
Flow in AV fistula measured with ultrasound
Measured: 1, 3, 6 and 12 months
Incidence of major adverse events
Major adverse events (death, stroke)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start17 Mar 2022
- Primary completion15 Jul 2024
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of Arteriovenous Dialysis FistulaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Arnsberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lichtenberg, Dr.med., Principal investigator, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232760
- Sponsor's protocol ID
- ASL202002
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
- ClinicalTrials.gov ID
- NCT05232760
- Acronym / sponsor ID
- ASL202002
- Keywords
- Juxta-anastomotic stenose of arteriovenous fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Klinikum ArnsbergUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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 purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.
Detailed description
Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUPERA peripheral stent system | – | Device: Supera™ Peripheral Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients from clinics with vascular centers
Key inclusion criteria (6 listed)
- Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy > 12 months.
- 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)
- Patients with at least one previous endovascular intervention to restore AVF function
- 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
- The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
Key exclusion criteria (8 listed)
- 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
- Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
- Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
- 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.
- Prior enrolment in this trial
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 |
|---|---|---|
| Supera™ Peripheral Stent SystemThe device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures | Device | SUPERA peripheral stent system |
Primary outcome
Number of patients with primary patency of juxta-anastomose at month 3
Time frame: 3 months
Primary patency is defined as clinically assessed intervention free (IFP) period
10 secondary outcomes
Number of patients with primary patency of juxta-anastomose
Time frame: 1, 6 and 12 months.
Number of patients with assisted primary patency
Time frame: 1, 3, 6 and 12 months
Number of patients with secondary patency
Time frame: 1, 3, 6 and 12 months
Number of patients with technical success
Time frame: Day 1 after the index procedure
Number of patients with procedural success
Time frame: 1 day (discharge)
Number of patients with clinical success
Time frame: 1 day (discharge)
Number of patients with access circuit patency
Time frame: 1,3,6,12 months
Recirculation rate
Time frame: 1, 3, 6 and 12 months
Fistula flow
Time frame: 1, 3, 6 and 12 months
Incidence of major adverse events
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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.
Michael Lichtenberg, Dr.med. principal investigator
Klinikum Hochsauerland GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenosis of Arteriovenous Dialysis Fistula, run by Klinikum Arnsberg at 1 site in Germany.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with primary patency of juxta-anastomose at month 3 (time frame: 3 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 28 Jan 2026.