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

Klinikum Arnsberg1 site in 1 country12 target enrollmentMarch 17, 2022

ConditionsStenosis of Arteriovenous Dialysis Fistula

InterventionsSupera™ Peripheral Stent System

Overview

Phase: Not Applicable
Intervention: Supera™ Peripheral Stent System
Conditions: Stenosis of Arteriovenous Dialysis Fistula
Sponsor: Klinikum Arnsberg
Enrollment: 12
Locations: 1
Primary Endpoint: Number of patients with primary patency of juxta-anastomose at month 3
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 17, 2022

End Date

April 2, 2025

Last Updated

3 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Klinikum Arnsberg

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months.
•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)
•Patients with at least one previous endovascular intervention to restore AVF function
•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
•The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
•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

•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
•Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
•Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
•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.
•Prior enrolment in this trial
•Women who are pregnant or lactating
•Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
•Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -

Arms & Interventions

SUPERA peripheral stent system

Intervention: Supera™ Peripheral Stent System

Outcomes

Primary Outcomes

Number of patients with primary patency of juxta-anastomose at month 3

Time Frame: 3 months

Primary patency is defined as clinically assessed intervention free (IFP) period

Secondary Outcomes

Number of patients with technical success(Day 1 after the index procedure)
Number of patients with access circuit patency(1,3,6,12 months)
Number of patients with primary patency of juxta-anastomose(1, 6 and 12 months.)
Number of patients with assisted primary patency(1, 3, 6 and 12 months)
Number of patients with secondary patency(1, 3, 6 and 12 months)
Recirculation rate(1, 3, 6 and 12 months)
Fistula flow(1, 3, 6 and 12 months)
Number of patients with procedural success(1 day (discharge))
Number of patients with clinical success(1 day (discharge))
Incidence of major adverse events(6 and 12 months)