NCT04327609View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

April 10, 2020

Primary Completion Date

February 1, 2024

Study Completion Date

July 23, 2025

Conditions
AV Fistula
Interventions
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.

DEVICE

Control Arm

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

Trial Locations (3)

Unknown

University of Athens, Athens

University of Patras, Pátrai

Singapore General Hospital LTD, Singapore

All Listed Sponsors
lead

M.A. Med Alliance S.A.

INDUSTRY

NCT04327609 - SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications | Biotech Hunter | Biotech Hunter