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

Overview

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.

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.

Eligibility

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 -