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

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ClinicalTrials.gov Identifier: NCT04327609
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
M.A. Med Alliance S.A.

Brief Summary:
Prospective dual-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.

Condition or disease Intervention/treatment Phase
AV Fistula Device: SELUTION SLR™ DEB Device: Control Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: SELUTION SLR™ DEB
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.
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.

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




Primary Outcome Measures :
  1. Primary Patency [ Time Frame: 6 months ]
    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.

  2. 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.


Secondary Outcome Measures :
  1. Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. [ Time Frame: 6 months ]
    Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.

  2. Late lumen loss [ Time Frame: 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.

  3. Device Success [ Time Frame: During Procedure ]
    Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.

  4. Anatomic success [ Time Frame: Immediately after angioplasty ]
    Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.

  5. Clinical Success [ Time Frame: 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.

  6. Binary Vessel Restenosis [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327609


Contacts
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Contact: Amanda Isula +01 2484443158 aisula@medalliance.com

Locations
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Greece
University of Athens Recruiting
Athens, Greece
Contact: Eric Brountzos, MD         
Sub-Investigator: Stavros Spiliopoulos, MD         
Principal Investigator: Eric Brountzos, MD         
University of Patras Recruiting
Patras, Greece
Contact: Katsanos Konstantinos, MD         
Principal Investigator: Katsanos Konstantinos, MD         
Sponsors and Collaborators
M.A. Med Alliance S.A.
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Responsible Party: M.A. Med Alliance S.A.
ClinicalTrials.gov Identifier: NCT04327609    
Other Study ID Numbers: SEL-001-2019
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical