SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
NCT ID: NCT04327609
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2020-04-10
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SELUTION SLR™ DEB
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.
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 Treatment
POBA
Control Arm
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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M.A. Med Alliance S.A.
INDUSTRY
Responsible Party
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Locations
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University of Athens
Athens, , Greece
University of Patras
Pátrai, , Greece
Singapore General Hospital LTD
Singapore, , Singapore
Countries
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Other Identifiers
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SEL-001-2019
Identifier Type: -
Identifier Source: org_study_id
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