Evaluating the Supera Stent for Dialysis Fistula Stenosis

SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis

This study is testing if the SUPERA stent can safely help people with dialysis fistulas who have narrowing in their blood vessels feel better and improve their blood flow.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Klinikum Arnsberg (other)
• Locations: 1 site (Arnsberg)
• Trial ID: NCT05232760 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of the SUPERA stent in treating juxta-anastomotic stenosis in patients with arteriovenous dialysis fistulas. Up to 50 hemodialysis patients with symptomatic stenosis will be enrolled and treated with the SUPERA stent, followed by regular follow-up assessments at 1, 3, 6, and 12 months post-procedure. The study focuses on improving hemodynamic outcomes through innovative stent design and placement techniques.

Who should consider this trial

Good fit: Ideal candidates are hemodialysis patients aged 18 and older with symptomatic juxta-anastomotic stenosis of their arteriovenous fistula.

Not a fit: Patients with nonsignificant stenosis or those not requiring intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the functionality and longevity of arteriovenous fistulas in hemodialysis patients.

How similar studies have performed: While this approach is exploratory, similar studies using stent interventions in vascular access have shown promising results.

Eligibility criteria

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 -

Where this trial is running

Arnsberg

• Klinikum Hochsauerland GmbH — Arnsberg, Germany (RECRUITING)

Study contacts

• Principal investigator: Michael Lichtenberg, Dr.med. — Klinikum Hochsauerland GmbH
• Study coordinator: Michael Lichtenberg, Dr.med.

Conditions: Stenosis of Arteriovenous Dialysis Fistula, Juxta-anastomotic stenose of arteriovenous fistula