IMPRESSION – A randomised trial to evaluate the efficacy of MagicTouch Sirolimus Coated Balloon in Dysfunctional Fistula progresses rapidly
PR90263
SINGAPORE, June 23, 2021 /PRNewswire=KYODO JBN/ --
Concept Medical Inc. [https://www.conceptmedical.com/], focused on vascular
intervention drug delivery devices, has updated the progress of IMPRESSION [
(sIroliMus coated balloon angioPlasty versus plain balloon angioplasty in the
tREatment of dialySis acceSs dysfunctION) randomised trial.
IMPRESSION [
is a prospective, multi-center, two-arm parallel group, randomised clinical
trial to compare the efficacy of Sirolimus Coated Balloon versus Placebo Plain
Balloon (control arm) in the treatment of dysfunctional (stenosed) fistula used
for vascular access in hemodialysis. A total of 170 patients with End Stage
Renal Disease (ESRD) are being randomised in 1:1 fashion (MagicTouch AVF
[https://www.conceptmedical.com/product/magic-touch-avf/]: Placebo Plain
Balloon).
The study's primary objective is to determine if the use of Sirolimus Coated
Balloon will result in an improvement of the primary circuit patency at six
months when compared head-to-head with plain balloon angioplasty (POBA). The
MagicTouch AVF [https://www.conceptmedical.com/product/magic-touch-avf/]
Sirolimus Coated Balloon has already been granted the Breakthrough Device
Designation by the U.S. Food and Drug Administration (FDA). Only ESRD patients
with a matured dysfunctional arterio-venous fistula (AVF) that has been in use
for at least one month prior to angioplasty will be enrolled.
The study is being conducted at three sites in Singapore led by Associate
Professor Chieh Suai Tan, Head and Senior Consultant, Department of Renal
Medicine, Singapore General Hospital (SGH), as the principal investigator.
Other site principal investigators include Associate Professor Edward Choke,
Senior Consultant, Department of Surgery, Sengkang General Hospital, and
Associate Professor Jackie Ho, Senior Consultant, Department of Cardiac,
Thoracic and Vascular Surgery, National University Heart Centre, Singapore. The
index patient was enrolled on 11th January 2021 and at the time of going to
press, 37 patients have been enrolled.
SGH was chosen to lead this randomised controlled trial because of its prior
experience using Sirolimus Coated Balloon in two investigator-initiated pilot
studies. The studies had shown that patency rates with the use of MagicTouch
AVF [https://www.conceptmedical.com/product/magic-touch-avf/] in thrombosed
arterio-venous graft (AVG) and dysfunctional AVF were 65 per cent and 82.9 per
cent at six months, respectively.
An operational vascular access such as AVF or (AVG) is vital in ESRD
patients for effective and long-term hemodialysis. Unfortunately, due to
various reasons, the AVF or AVG may narrow (stenosis), resulting in poor flow
of the vascular access, which affects hemodialysis. The functional life of an
AVF is poor with as high as 50 per cent chance of failure after a median of
three to seven years.
Singapore has one of the highest ESRD incident rates globally. POBA is the
current standard treatment for patients with AVF stenosis. Despite the
minimally invasive nature of POBA procedure, the long-term patency is poor,
averaging 40 to 50 per cent at one year. This necessitates multiple procedures
in order to maintain patency of the vascular access.
Paclitaxel Coated Balloon is also being used to treat dysfunctional AVF with
mixed success. However, the safety concerns of Paclitaxel raised by the U.S.
FDA and the issue of guidelines by the interventional societies have prompted
doctors to seek a better alternative.
Photo:https://mma.prnewswire.com/media/1549682/IMPRESSION_Concept_Medical.jpg
Logo:https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg
Source: Concept Medical
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