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
|Condition or disease||Intervention/treatment||Phase|
|AV Fistula||Device: SELUTION SLR™ DEB Device: Control Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
Device: Control Arm
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
- 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.
- 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.
- 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.
- 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.
- 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.
- Anatomic success [ Time Frame: Immediately after angioplasty ]Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty.
- 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.
- 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.
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
|Contact: Amanda Isula||+01 firstname.lastname@example.org|
|University of Athens||Recruiting|
|Contact: Eric Brountzos, MD|
|Sub-Investigator: Stavros Spiliopoulos, MD|
|Principal Investigator: Eric Brountzos, MD|
|University of Patras||Recruiting|
|Contact: Katsanos Konstantinos, MD|
|Principal Investigator: Katsanos Konstantinos, MD|