Concept Medical Inc. Advances IMPRESSION Trial of Sirolimus-Coated Balloon for Dysfunctional Dialysis Access

SINGAPORE, June 24, 2021 /PRNewswire/ -- specializing in vascular interventional drug delivery devicesConcept Medical Inc.UpdatedIMPRESSION（sIroliMus coated balloon angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION, West(Comparison of Sirolimus-Coated Balloon Angioplasty versus Plain Balloon Angioplasty for the Treatment of Dysfunctional Dialysis Access) Randomized Trial Update.

IMPRESSIONis a prospective, multicenter, two-arm, parallel, randomized clinical trial designed to compare the efficacy of a sirolimus-coated balloon versus a placebo plain balloon (control group) for the treatment of dysfunctional (stenotic) fistulas used for vascular access in hemodialysis. A total of 170 patients with end-stage renal disease (ESRD) were randomized in a 1:1 (MagicTouch AVF: placebo plain balloon) were randomized.

The primary objective of this study is to determine whether sirolimus-coated balloon angioplasty improves primary patency at 6 months in a head-to-head comparative clinical trial against plain old balloon angioplasty (POBA).MagicTouch AVFThe sirolimus-coated balloon has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Enrollment is limited to patients with end-stage renal disease (ESRD) who have a mature, dysfunctional arteriovenous fistula (AVF) that has been in use for at least one month prior to angioplasty.

The study is being conducted across three research centers in Singapore, with Associate Professor Chieh Suai Tan, Director and Senior Consultant of the Department of Renal Medicine at Singapore General Hospital, serving as the Principal Investigator. Other Principal Investigators include Associate Professor Edward Choke, Senior Consultant in the Department of Surgery at Sengkang General Hospital, and Associate Professor Jackie Ho, Senior Consultant in the Department of Cardiac, Thoracic and Vascular Surgery at the National University Heart Centre, Singapore. Enrollment of treatment-naïve patients began on January 11, 2021, and as of press time, 37 patients have been enrolled.

Given SGH's experience using sirolimus-coated balloons in two previous investigator-initiated pilot studies, it was selected as the lead center for this randomized controlled trial. Studies have shown that the use for thrombosed arteriovenous grafts (AVGs) and dysfunctional AVFsMagicTouch AVFThe 6-month patency rates were 65% and 82.9%, respectively.

In patients with end-stage renal disease (ESRD), surgical vascular access such as an arteriovenous fistula (AVF) or arteriovenous graft (AVG) is essential for effective and long-term hemodialysis. Unfortunately, due to various factors, AVFs or AVGs may develop stenosis (narrowing), resulting in inadequate vascular access flow that subsequently compromises hemodialysis. The functional lifespan of AVFs is relatively limited, with a failure rate of up to 50% within three to seven years.

Singapore is one of the countries with the highest ESRD incidence rates globally. POBA is currently the standard treatment for patients with AVF stenosis. Despite the minimally invasive nature of POBA, it is associated with poor long-term patency, with a one-year average patency rate of 40% to 50%. To maintain vascular access patency, repeated procedures are required.

Paclitaxel-coated balloons have also been used to treat dysfunctional AVFs, with mixed results. However, safety concerns regarding paclitaxel raised by the U.S. FDA, along with guideline-related concerns from interventional societies, have prompted physicians to seek better alternatives.