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

PR85583

SINGAPORE, Sept. 14, 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 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.

    FUTURE SFA [https://www.conceptmedical.com/press-release/future-sfa-enrolment/ ]

is a randomized, double blind, placebo-controlled, multi-center trial to determine

the effectiveness of MagicTouch PTA [https://www.conceptmedical.com/product/magic-touch-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)

[https://www.conceptmedical.com/product/magic-touch-pta/ ] 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[https://www.conceptmedical.com/product/magic-touch-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[https://www.conceptmedical.com/technology/nanolute/ ] 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 years.

     [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)]

www.conceptmedical.com 

    Photo: https://mma.prnewswire.com/media/1273493/Future_SFA_Enrollment.jpg 

    Caption: Enrolment of the first patient in the FUTURE SFA by Dr. Edward

Choke and his team at Sengkang General Hospital Singapore.

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

    Source: Concept Medical