Trials / Completed
CompletedNCT05232760
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Klinikum Arnsberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Supera™ Peripheral Stent System | The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures |
Timeline
- Start date
- 2022-03-17
- Primary completion
- 2024-07-15
- Completion
- 2025-04-02
- First posted
- 2022-02-10
- Last updated
- 2026-01-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05232760. Inclusion in this directory is not an endorsement.