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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Subjects will receive standard high-pressure balloon angioplasty followed by local application of sirolimus with the SELUTION SLR™ 018 DEB (MedAlliance) of appropriate diameter and length to achieve full lesion coverage.
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
University of Athens
Athens, Greece
University of Patras
Pátrai, Greece
Singapore General Hospital LTD
Singapore, Singapore
Primary Patency of the treated lesion at 6 months post-intervention.
Primary patency: Defined as 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.
Time frame: 6 months
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
Time frame: 30 days
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
Time frame: 6 months
Late lumen loss
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.
Time frame: 6 months
Device Success
Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.
Time frame: During Procedure
Anatomic success
Anatomic success: Defined as \<30% residual stenosis diameter measured immediately after angioplasty.
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Time frame: Immediately after angioplasty
Clinical Success
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.
Time frame: 6 months
Binary Vessel Restenosis
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.
Time frame: 6 months