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

Primary Purpose

AV Fistula

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SELUTION SLR™ DEB
Control Arm
Sponsored by
M.A. Med Alliance S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AV Fistula

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Athens
  • University of Patras
  • Singapore General Hospital LTD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SELUTION SLR™ DEB

Control Treatment

Arm Description

Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.

POBA

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Device Success
Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.
Anatomic success
Anatomic success: Defined as <30% residual stenosis diameter measured 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.
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.

Full Information

First Posted
February 20, 2020
Last Updated
August 11, 2023
Sponsor
M.A. Med Alliance S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04327609
Brief Title
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Acronym
SAVE
Official Title
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.A. Med Alliance S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AV Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SELUTION SLR™ DEB
Arm Type
Experimental
Arm Description
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.
Arm Title
Control Treatment
Arm Type
Active Comparator
Arm Description
POBA
Intervention Type
Device
Intervention Name(s)
SELUTION SLR™ DEB
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Arm
Intervention Description
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
Primary Outcome Measure Information:
Title
Primary Patency
Description
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.
Time Frame
6 months
Title
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
Description
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
Description
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
Time Frame
6 months
Title
Late lumen loss
Description
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
Title
Device Success
Description
Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.
Time Frame
During Procedure
Title
Anatomic success
Description
Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.
Time Frame
Immediately after angioplasty
Title
Clinical Success
Description
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
Title
Binary Vessel Restenosis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Athens
City
Athens
Country
Greece
Facility Name
University of Patras
City
Patras
Country
Greece
Facility Name
Singapore General Hospital LTD
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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