SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
- Conditions
- AV Fistula
- Interventions
- Device: SELUTION SLR™ DEBDevice: Control Arm
- Registration Number
- NCT04327609
- Lead Sponsor
- M.A. Med Alliance S.A.
- 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 treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SELUTION SLR™ DEB SELUTION SLR™ DEB Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. Control Treatment Control Arm POBA
- Primary Outcome Measures
Name Time Method Primary Patency 6 months Primary patency: Defined as number of patients with uninterrupted patency after the initial intervention with regular ongoing dialysis until symptomatic recurrent stenosis of the dialysis circuit, or thrombosis, mandating repeat treatment, or further surgical intervention of the access circuit or eventual failure/abandonment of the circuit with creation of alternative access for dialysis. This endpoint will be analysed cumulatively at 6 months and with time-to-event methods (e.g. Kaplan Meier) on extended follow-up period to 2 years.
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days 30 days Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
- Secondary Outcome Measures
Name Time Method Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. 6 months Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
Device Success During Procedure Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.
Late lumen loss 6 months Late lumen loss (LLL) defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.
Anatomic success Immediately after angioplasty Anatomic success: Defined as \<30% residual stenosis diameter measured immediately after angioplasty.
Clinical Success 6 months Clinical Success: Defined as an improvement from baseline in the clinical or hemodynamic parameter (e.g., blood flow, venous pressures) that was the initial indicator of fistula dysfunction and the resumption of normal hemodialysis for a minimum of at least 1 session following the procedure.
Binary Vessel Restenosis 6 months Binary vessel restenosis: Angiographic restenosis rate defined as the incidence of stenosis ≥50% of the diameter of the reference vessel segment within the treated target lesion.
Trial Locations
- Locations (3)
University of Patras
🇬🇷Patras, Greece
University of Athens
🇬🇷Athens, Greece
Singapore General Hospital LTD
🇸🇬Singapore, Singapore