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

AV Fistula Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04327609
• Other study ID #: SEL-001-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: M.A. Med Alliance S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 31, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• AV Fistula
• Fistula

Intervention

Device:
• SELUTION 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.
• Control Arm
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.

Locations

Country	Name	City	State
Greece	University of Athens	Athens
Greece	University of Patras	Patras
Singapore	Singapore General Hospital LTD	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
M.A. Med Alliance S.A.

Countries where clinical trial is conducted

Greece,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency	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.	6 months
Primary	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.	30 days
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Device Success	Device Success: Defined as successful balloon inflation of the SELUTION catheter for =2 minutes and retrieval of the catheter.	During Procedure
Secondary	Anatomic success	Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.	Immediately after angioplasty
Secondary	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.	6 months
Secondary	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.	6 months