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

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.

Study Overview

• Status: Completed
• Conditions: AV Fistula
• Intervention / Treatment: Device: SELUTION SLR™ DEB; Device: Control Arm

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • University of Athens
  • Pátrai, Greece
    • University of Patras
• Singapore
  • Singapore, Singapore
    • Singapore General Hospital LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SELUTION SLR™ DEB; Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.	Device: SELUTION SLR™ DEB; 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.
Active Comparator: Control Treatment; POBA	Device: Control Arm; The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Primary Patency of the treated lesion at 6 months post-intervention.	Primary patency: Defined as 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

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

Collaborators and Investigators

• Sponsor: M.A. Med Alliance S.A.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): July 23, 2025

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: SEL-001-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No