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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04327609
Other study ID # SEL-001-2019
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 10, 2020
Est. completion date December 31, 2025

Study information

Verified date June 2024
Source M.A. Med Alliance S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date December 31, 2025
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Control Arm
The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.

Locations

Country Name City State
Greece University of Athens Athens
Greece University of Patras Patras
Singapore Singapore General Hospital LTD Singapore

Sponsors (1)

Lead Sponsor Collaborator
M.A. Med Alliance S.A.

Countries where clinical trial is conducted

Greece,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Patency 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. 6 months
Primary 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. 30 days
Secondary 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. 6 months
Secondary 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. 6 months
Secondary Device Success Device Success: Defined as successful balloon inflation of the SELUTION catheter for =2 minutes and retrieval of the catheter. During Procedure
Secondary Anatomic success Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty. Immediately after angioplasty
Secondary 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. 6 months
Secondary 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. 6 months
See also
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Completed NCT01471041 - Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae Phase 2/Phase 3
Not yet recruiting NCT05569109 - av Fistula Patency Loss as a Cause of Fistula Failure and Hyperphosphatemia
Completed NCT02475837 - Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access Phase 2
Active, not recruiting NCT04484220 - Ellipsys Vascular Access System Post Market Surveillance (PS) Study N/A