PR85295

SINGAPORE, Aug. 27, 2020 /PRNewswire=KYODO JBN/ --

    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.