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

• Sponsor: M.A. Med Alliance S.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04327609
• Collaborator: (none)
• Enrollment: 84
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 36.7
• Patients Per Site: 42
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 10, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Primary Patency [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 [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. [6 months]

   Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.

2. Late lumen loss [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 [During Procedure]

   Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter.

4. Anatomic success [Immediately after angioplasty]

   Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.

5. Clinical Success [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Athens	Athens		Greece
2	University of Patras	Patras		Greece

Sponsors and Collaborators

• M.A. Med Alliance S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M.A. Med Alliance S.A.
• ClinicalTrials.gov Identifier: NCT04327609
• Other Study ID Numbers: SEL-001-2019
• First Posted: Mar 31, 2020
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fistula

Study Results

No Results Posted as of Apr 6, 2022