Status:
COMPLETED
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Lead Sponsor:
M.A. Med Alliance S.A.
Conditions:
AV Fistula
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04327609
Start Date
April 10 2020
End Date
July 23 2025
Last Update
August 29 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Athens
Athens, Greece
2
University of Patras
Pátrai, Greece
3
Singapore General Hospital LTD
Singapore, Singapore