Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, September 15 2020 - 01:10
Concept Medical announces index patient enrolment in world's first Randomized Controlled Trial with Sirolimus Coated Balloon for the treatment of Superficial Femoral Artery (SFA) in Peripheral Artery Disease
SINGAPORE, Sept. 14, 2020 /PRNewswire/ AsiaNet/ --

    Concept Medical Inc.[], focused on vascular 
intervention drug delivery devices, has announced the enrolment of the first 
patient in the FUTURE SFA (Randomized Controlled Trial of First SirolimUs 
CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of 
Superficial Femoral Artery and Popliteal Artery Disease).

    The index patient was successfully enrolled on 11th September in Singapore.

SFA[] is a 
randomized, double blind, placebo-controlled, multi-center trial to determine 
the effectiveness of MagicTouch 
PTA[] sirolimus drug 
coated balloon versus standard percutaneous transluminal angioplasty for the 
treatment of superficial femoral and popliteal arterial disease.

    The burden of peripheral arterial disease (PAD) is high globally. Its 
burden is likely to grow in the coming years given the rising trends in key 
risk factors such as age and diabetes. In its most advanced stage, patients 
present as critical limb ischemia (CLI) and many end up with leg amputations.

    Current standard of care for severe PAD is revascularization, the majority 
of which involves the use of balloon angioplasty to unblock the vessel and 
restore blood flow to the leg. However, these vessels frequently become blocked 
again, resulting in repeated procedures which is potentially dangerous and may 
result in loss of limb or even life. 

    Local drug delivery using drug coated balloons 
(DCBs)[] during 
angioplasty can successfully deliver anti-proliferative drugs to the lesions in 
the artery, with the aim of keeping the vessel open for longer. Sirolimus 
coated balloons are considered to be the next new generation of DCBs and the 
novel MagicTouch PTA[] 
sirolimus coated balloon (SCB), has emerged as one of the most promising 
transcatheter technologies in preventing restenosis for diseased arteries.

    The principal investigator of FUTURE-SFA is Associate Professor Edward 
Choke from the Department of General Surgery (Vascular Surgery) at the Sengkang 
General Hospital, Singapore. 

    Associate Professor Edward Choke said, "I am inspired by the bold, 
imaginative and futuristic concepts presented by the Nanolute 
technology[] of the 
MagicTouch PTA sirolimus coated balloon. In contrast to other contemporary 
technologies, MagicTouch PTA offers a solution which optimizes both the 
deliverability and the absorption of sirolimus into the vessel wall."

    He added, "Initial experience with the XTOSI first in man study suggested 
that MagicTouch PTA can provide an effective way of revascularization for PAD 
patients, by keeping the vessels open longer and reducing the need of repeated 
angioplasty procedures. I look forward to the FUTURE-SFA randomized controlled 
trial, which will test whether the Magic Touch PTA sirolimus coated balloon can 
improve the patencies of femoral and popliteal arteries in PAD patients. We 
hope to establish whether SCB will emerge as the new standard of care which 
will impact the way we treat PAD."

     The trial will enrol 153 patients with Rutherford class 3 to 6 PAD. These 
subjects will be randomized in 2:1 fashion to receive either 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 
minimise 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 

     [NCT04511234 - Randomized Controlled Trial of First Sirolimus Coated 
Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial 
Femoral Artery and Popliteal Artery Disease (FUTURE-SFA)] 

    Caption: Enrolment of the first patient in the FUTURE SFA by Dr. Edward 
Choke and his team at Sengkang General Hospital Singapore.


    Source: Concept Medical