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

Launched by M.A. MED ALLIANCE S.A. · Mar 30, 2020

Keywords

ClinConnect Summary

The SAVE Trial is a study looking at a new treatment option for patients with a problem in their arteriovenous (AV) fistula, which is a connection made for dialysis access. In this trial, researchers are comparing a special balloon called the SELUTION SLR™ that releases medication to help treat the blockage in the AV fistula, against a standard treatment. The goal is to see if this new balloon is safe and effective for patients who have had issues with their dialysis access.

To participate in the trial, individuals need to be between 18 and 90 years old and must have a functioning dialysis access that has worked at least once. They should have a blockage that is causing problems and meets specific size criteria. However, some patients may not qualify, such as those with certain severe health issues or infections. Those who do participate can expect to receive either the new balloon treatment or the standard treatment, and they will be monitored throughout the study to ensure their safety and track the treatment's effectiveness. This study is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• 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.