SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications

Study Overview
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Brief Summary
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Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.

Official Title
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SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications

Conditions
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AV Fistula

Intervention / Treatment
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* Device: SELUTION SLR™ DEB
* Device: Control Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 years Patient is able and willing to provide written informed consent A Dialysis Access that has performed at least 1 successful dialysis session Stenosis >50% at the outflow vein (by visual estimation) with clinical circuit dysfunction Lesion of ≤7mm in diameter Lesion of up to the 70mm in length Exclusion Criteria: Life expectancy <1year Lower extremity AVG Infected AVG Uncontrolled systemic infection Aneurysm or pseudoaneurysm in proposed target lesion Presence of previous CS or BMS ≥2 lesions present within the circuit Unable to perform protocol prescribed pre-dilation of the lesion Patient is female and is pregnant, or planning to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELUTION SLR™ DEB<br>Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. | Device: SELUTION SLR™ DEB<br>* Subjects will receive standard high-pressure balloon angioplasty followed by local application of sirolimus with the SELUTION SLR™ 018 DEB (MedAlliance) of appropriate diameter and length to achieve full lesion coverage.<br>|
| Active Comparator: Control Treatment<br>POBA | Device: Control Arm<br>* The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Primary patency: Defined as number of patients with uninterrupted patency after the initial intervention with regular ongoing dialysis until symptomatic recurrent stenosis of the dialysis circuit, or thrombosis, mandating repeat treatment, or further surgical intervention of the access circuit or eventual failure/abandonment of the circuit with creation of alternative access for dialysis. This endpoint will be analysed cumulatively at 6 months and with time-to-event methods (e.g. Kaplan Meier) on extended follow-up period to 2 years. | 6 months | 
| Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days | Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. | Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. | 6 months | 
| Late lumen loss | Late lumen loss (LLL) defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram. | 6 months | 
| Device Success | Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter. | During Procedure | 
| Anatomic success | Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty. | Immediately after angioplasty | 
| Clinical Success | Clinical Success: Defined as an improvement from baseline in the clinical or hemodynamic parameter (e.g., blood flow, venous pressures) that was the initial indicator of fistula dysfunction and the resumption of normal hemodialysis for a minimum of at least 1 session following the procedure. | 6 months | 
| Binary Vessel Restenosis | Binary vessel restenosis: Angiographic restenosis rate defined as the incidence of stenosis ≥50% of the diameter of the reference vessel segment within the treated target lesion. | 6 months |