Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, August 27 2020 - 20:57
AsiaNet
Enrolment initiated in World's First RCT with Sirolimus Coated Balloon for the treatment of Below-the-Knee (BTK) Peripheral Artery Disease
SINGAPORE, Aug. 27, 2020 /PRNewswire-AsiaNet/ --

    Concept Medical Inc. (https://www.conceptmedical.com/), focused on vascular 
intervention drug delivery devices, has announced the enrolment of the first 
patient in the FUTURE BTK (trial (Randomized Controlled Trial of First 
SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment 
of Below The Knee Artery Disease).

    The index patient was successfully enrolled on 26th August 2020 in 
Singapore.

    FUTURE BTK is a randomized, double blind, placebo-controlled, multi-center 
trial. It is aimed at determining the effectiveness of MagicTouch PTA 
(https://www.conceptmedical.com/product/magic-touch-pta/) sirolimus coated 
balloon versus standard balloon angioplasty for the treatment of below the knee 
arterial disease in critical limb ischemia (CLI) patients. 

    Treatment of CLI primarily involves revascularization of below the knee 
arteries using angioplasty. Local drug delivery using drug coated balloons 
(DCBs) during angioplasty can successfully deliver anti-proliferative drugs to 
the lesions in the artery, and prevent restenosis. Sirolimus coated balloons 
(https://www.conceptmedical.com/product/magic-touch-pta/) are considered to be 
the next new generation of DCBs, and MagicTouch PTA sirolimus coated balloon 
offers a solution which optimizes both the deliverability and the absorption of 
sirolimus into the vessel wall. 

    The principal investigator of FUTURE-BTK ( 
https://www.conceptmedical.com/press-release/worlds-first-rct-with-sirolimus-coated-balloon/) 
is Associate Professor Edward Choke from the Department of General Surgery 
(Vascular Surgery) at the Sengkang General Hospital, Singapore. 

    Associate Professor Edward Choke said, "Critical limb ischemia is a 
condition which puts patients at an increased risk of limb amputation and 
death. Its burden is likely to grow in the coming years given the rising trends 
in key risk factors such as age and diabetes. Effective revascularization is 
the cornerstone of treatment, but this is often hampered by high rates of 
restenosis and reintervention after conventional balloon angioplasty."

    He added, "The novel MagicTouch PTA sirolimus coated balloon has emerged as 
one of the most promising transcatheter technologies in preventing restenosis 
for below-the-knee lesions. The earlier data on the efficacy of MagicTouch PTA 
from small studies are encouraging but these need to be confirmed or refuted. I 
look forward to the FUTURE BTK randomized controlled trial, which will test 
whether the MagicTouch PTA sirolimus coated balloon can improve the patency of 
below the knee arteries in CLI patients, and this will hopefully bring us 
closer to our goal of reducing leg amputations."

    The trial will enroll 210 patients with Rutherford class-4 to -6 CLI. These 
subjects will be randomized in 2:1 fashion to receive either MagicTouch PTA 
(https://www.conceptmedical.com/product/magic-touch-pta/)  or standard balloon 
angioplasty.  Primary outcome will be primary patency at 6 months, defined as 
duplex peak systolic velocity ratio (PSVR) of 2.4 or less. 

    The trial is designed to follow a rigorous blinding protocol in order to 
minimize bias. Patients, care providers, investigators and outcome assessors, 
including vascular technologists performing the duplex ultrasound, will be 
blinded to the treatment allocations. The patients will be followed up for two 
years. 


    www.conceptmedical.com

    Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg

    Photo: 
https://mma.prnewswire.com/media/1244677/Concept_Medical_FUTURE_BTK_Trial.jpg
    
    Photo Caption: Enrolment of the first patient in (FUTURE BTK CLINICAL 
TRIAL) World’s First RCT with Sirolimus Coated Balloon for the Treatment of 
Peripheral Artery Disease in Below-the-Knee (BTK) by Dr Edward Choke and his 
team at Sengkang General Hospital – Singapore.
 
    Source: Concept Medical Inc.
Translations

Japanese