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

Inclusion Criteria:

1. Patients must be ≥ 18 years of age, able to perform follow-up visits, have a lifeexpectancy > 12 months.

2. Hemodialysis patients undergoing endovascular angioplasty due to a clinicallysymptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalicAVF with significant stenosis (lumen diameter < 2.7mm)

3. Patients with at least one previous endovascular intervention to restore AVFfunction

4. The target lesion consists of one or more lesions with a target lesion length ofless than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalicAVF

5. The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (inangiographic or ultrasound evaluation)

6. If there are other non-target lesions, then non-target lesions must be successfullycured 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 toanticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannotbe 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 anyinvestigational drug or device that may potentially confound the results of thestudy, or that would limit the patient's compliance with the follow-up requirementsof 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 -