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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stenosis of Arteriovenous Dialysis Fistula

Intervention / Treatment
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* Device: Supera™ Peripheral Stent System


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SUPERA peripheral stent system<br> | Device: Supera™ Peripheral Stent System<br>* The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with primary patency of juxta-anastomose | Primary patency is defined as clinically assessed intervention free (IFP) period | 1, 6 and 12 months. | 
| Number of patients with assisted primary patency | 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 | 1, 3, 6 and 12 months | 
| Number of patients with secondary patency | 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 | 1, 3, 6 and 12 months | 
| Number of patients with technical success | Residual stenosis < 30% after treatment with Supera stent (measured by angiography during the procedure) | Day 1 after the index procedure | 
| Number of patients with procedural success | Residual stenosis < 30% with no major adverse events (MAE) | 1 day (discharge) | 
| Number of patients with clinical success | Hemodialysis access function improved, dialysis function restored, and at least one dialysis session completed after the procedure until discharge | 1 day (discharge) | 
| Number of patients with access circuit patency | Freedom from development of a stenosis in any region of the AVF circuit, including the juxta-anastomotic segment | 1,3,6,12 months | 
| Recirculation rate |  | 1, 3, 6 and 12 months | 
| Fistula flow | Flow in AV fistula measured with ultrasound | 1, 3, 6 and 12 months | 
| Incidence of major adverse events | Major adverse events (death, stroke) | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juxta-anastomotic stenose of arteriovenous fistula