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

Last updated: July 31, 2023
Sponsor: Klinikum Arnsberg
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Supera™ Peripheral Stent System

Clinical Study ID

NCT05232760
ASL202002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 AVF function
  4. The target lesion consists of one or more lesions with a target lesion length of lessthan 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 (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

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 cannot beadequately pre-medicated.
  3. Patients with any contraindications as mentioned in the Instructions for Use (IFU) ofthe study device.
  4. Patients that are currently participating in another clinical trial involving anyinvestigational 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 thestudy.
  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 -

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Supera™ Peripheral Stent System
Phase:
Study Start date:
March 17, 2022
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • Klinikum Hochsauerland GmbH

    Arnsberg, 59759
    Germany

    Active - Recruiting

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