NCT05232760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 17, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

November 23, 2021

Last Update Submit

January 26, 2026

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Keywords

Juxta-anastomotic stenose of arteriovenous fistula

Outcome Measures

Primary Outcomes (1)

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

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

    3 months

Secondary Outcomes (10)

  • 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

  • Number of patients with technical success

    Day 1 after the index procedure

  • Number of patients with procedural success

    1 day (discharge)

  • +5 more secondary outcomes

Study Arms (1)

SUPERA peripheral stent system

Device: Supera™ Peripheral Stent System

Interventions

Supera™ Peripheral Stent SystemDEVICE

The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures

SUPERA peripheral stent system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemodialysis patients from clinics with vascular centers

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

Study Officials

  • Michael Lichtenberg, Dr.med.

    Klinikum Hochsauerland GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

February 10, 2022

Study Start

March 17, 2022

Primary Completion

July 15, 2024

Study Completion

April 2, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

DE(1)