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Completed

NCT Number: NCT04327609

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

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.

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Key information

Conditions

AV Fistula Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Athens, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SELUTION SLR™ DEB

Device

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.

Control arm

Device

The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.

Primary outcomes

  1. Primary Patency of the treated lesion at 6 months post-intervention.

    Time frame: 6 months

    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.

  2. Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days

    Time frame: 30 days

    Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.

Secondary outcomes

  1. Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.

    Time frame: 6 months

    Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.

  2. Late lumen loss

    Time frame: 6 months

    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.

  3. Device Success

    Time frame: During Procedure

    Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.

  4. Anatomic success

    Time frame: Immediately after angioplasty

    Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.

  5. Clinical Success

    Time frame: 6 months

    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. Binary Vessel Restenosis

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

M.A. Med Alliance S.A.

Industry

Registry information

Acronym: SAVE

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Mar 31, 2020
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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