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

M.A. Med Alliance

Status: Completed

Conditions: AV Fistula

Treatments: Device: SELUTION SLR™ DEB; Device: Control Arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04327609

SEL-001-2019

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

SELUTION SLR™ DEB

Experimental group

Description:

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

Treatment:

Device: SELUTION SLR™ DEB

Control Treatment

Active Comparator group

Description:

POBA

Treatment:

Device: Control Arm