AV Fistula
Conditions
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.
Interventions
DEVICESELUTION SLR™ DEB
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.
DEVICEControl Arm
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
Sponsors
M.A. Med Alliance S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency of the treated lesion at 6 months post-intervention. | 6 months | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Device Success | During Procedure | Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter. |
| Anatomic success | Immediately after angioplasty | Anatomic success: Defined as \<30% residual stenosis diameter measured immediately after angioplasty. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Greece, Singapore
Outcome results
None listed