NCT04327609

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

February 20, 2020

Last Update Submit

August 23, 2025

Conditions

AV Fistula

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

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

    6 months

  • Late lumen loss

    6 months

  • Device Success

    During Procedure

  • Anatomic success

    Immediately after angioplasty

  • Clinical Success

    6 months

  • +1 more secondary outcomes

Study Arms (2)

SELUTION SLR™ DEB

EXPERIMENTAL

Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.

Device: SELUTION SLR™ DEB

Control Treatment

ACTIVE COMPARATOR

POBA

Device: Control Arm

Interventions

SELUTION SLR™ DEBDEVICE

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.

SELUTION SLR™ DEB
Control ArmDEVICE

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

Control Treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Athens

Athens, Greece

Location

University of Patras

Pátrai, Greece

Location

Singapore General Hospital LTD

Singapore, Singapore

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 31, 2020

Study Start

April 10, 2020

Primary Completion

February 1, 2024

Study Completion

July 23, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

GR(2)SG(1)