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

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.

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.