AV FistulaSAVENCT04327609
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
A study testing SELUTION SLR™ DEB in people with AV Fistula, run by M.A. Med Alliance S.A. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- AV Fistula
- What is being tested?
- SELUTION SLR™ DEB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Apr 2020to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy <1year
- Lower extremity AVG
- Infected AVG
- Uncontrolled systemic infection
- Aneurysm or pseudoaneurysm in proposed target lesion
- Presence of previous CS or BMS
Show all 9Show fewer
- ≥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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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.
- Conditions
- AV Fistula
- Being tested
- SELUTION SLR™ DEB, Control Arm
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SELUTION SLR™ DEBDevice
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 ArmDevice
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
| Study group | Role | What they receive |
|---|---|---|
| SELUTION SLR™ DEB | Experimental | Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. Receives: Device: SELUTION SLR™ DEB |
| Control Treatment | Active comparator | POBA Receives: Device: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 6 months
Device Success
Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.
Measured: During Procedure
Anatomic success
Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start10 Apr 2020
- Primary completion1 Feb 2024
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.A. Med Alliance S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327609
- Sponsor's protocol ID
- SEL-001-2019
- Acronym
- SAVE
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2020
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
- ClinicalTrials.gov ID
- NCT04327609
- Acronym / sponsor ID
- SAVE / SEL-001-2019
- Conditions
- AV Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.A. Med Alliance S.A.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SELUTION SLR™ DEB | Experimental | Device: SELUTION SLR™ DEBMed Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. |
| Control Treatment | Active comparator | Device: Control ArmPOBA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Life expectancy <1year
- Lower extremity AVG
- Infected AVG
- Uncontrolled systemic infection
- Aneurysm or pseudoaneurysm in proposed target lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SELUTION SLR™ DEBSubjects 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. | Device | SELUTION SLR™ DEB |
| Control ArmThe control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment. | Device | Control Treatment |
Primary outcome
Primary Patency of the treated lesion at 6 months post-intervention.
Time frame: 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
Time frame: 30 days
Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days.
6 secondary outcomes
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
Time frame: 6 months
Device Success
Time frame: During Procedure
Anatomic success
Time frame: Immediately after angioplasty
Clinical Success
Time frame: 6 months
Binary Vessel Restenosis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELUTION SLR™ DEB in people with AV Fistula, run by M.A. Med Alliance S.A. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency of the treated lesion at 6 months post-intervention. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.