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

Recruiting

• Conditions: Stenosis of Arteriovenous Dialysis Fistula
• Interventions: Device: Supera™ Peripheral Stent System

• Registration Number: NCT05232760
• Lead Sponsor: Klinikum Arnsberg

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Study Start: 2022-03-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUPERA peripheral stent system	Supera™ Peripheral Stent System	-

Primary Outcome Measures

Name	Time	Method
Number of patients with primary patency of juxta-anastomose at month 3	3 months	Primary patency is defined as clinically assessed intervention free (IFP) period

Secondary Outcome Measures

Name	Time	Method
Number of patients with technical success	Day 1 after the index procedure	Residual stenosis \< 30% after treatment with Supera stent (measured by angiography during the procedure)
Number of patients with primary patency of juxta-anastomose	1, 6 and 12 months.	Primary patency is defined as clinically assessed intervention free (IFP) period
Number of patients with assisted primary patency	1, 3, 6 and 12 months	Assisted primary patency is defined as interval until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access
Number of patients with secondary patency	1, 3, 6 and 12 months	Secondary patency is defined as interval until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access
Number of patients with procedural success	1 day (discharge)	Residual stenosis \< 30% with no major adverse events (MAE)
Recirculation rate	1, 3, 6 and 12 months
Fistula flow	1, 3, 6 and 12 months	Flow in AV fistula measured with ultrasound
Number of patients with clinical success	1 day (discharge)	Hemodialysis access function improved, dialysis function restored, and at least one dialysis session completed after the procedure until discharge
Number of patients with access circuit patency	1,3,6,12 months	Freedom from development of a stenosis in any region of the AVF circuit, including the juxta-anastomotic segment
Incidence of major adverse events	6 and 12 months	Major adverse events (death, stroke)

Trial Locations

Locations (1)

Klinikum Hochsauerland GmbH; 🇩🇪 Arnsberg, Germany