Enrolment initiated in World’s First RCT with Sirolimus Coated Balloon for the treatment of Below-the-Knee Peripheral Artery Disease

Enrolment initiated in World’s First RCT with Sirolimus Coated Balloon for the treatment of Below-the-Knee (BTK) Peripheral Artery Disease

Concept Medical Inc. 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-centre trial. It is aimed at determining the effectiveness of MagicTouch 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 critical limb ischemia 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 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 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 enrol 210 patients with Rutherford class4 to 6 CLI. These subjects will be randomized in 2:1 fashion to receive either MagicTouch PTA or standard balloon angioplasty. 

The primary outcome will be the 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.

For more information about the FUTURE-BTK trial, please visit www.clinicaltrials.gov

[NCT04511247 – Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Artery Disease (FUTURE-BTK)]

In an ongoing single-arm clinical study (XTOSI) – world’s first pilot study of sirolimus coated balloon for 50 patients with peripheral arterial disease, promising results were seen in a challenging cohort of mostly CLI patients. Device success and technical success were both 100%. At 6 months, primary patency was 80%, freedom from clinically-driven target lesion revascularization (TLR) was 90.5%; and amputation free survival was 85.7%.

 

About MagicTouch PTA:

MagicTouch PTA is the first drug-coated balloon, that has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA), for the treatment of Below-the-Knee (BTK) Peripheral Artery Disease (PAD). MagicTouch PTA is a CE approved and commercially marketed sirolimus coated balloon, developed using proprietary Nanolute Technology. MagicTouch has been deployed in >50,000 patients in major global markets. Nanolute – the unique drug delivery technology platform of MagicTouch PTA balloon, is designed to deliver sub-micron particles of sirolimus which are then encapsulated in a biocompatible drug carrier. The carrier-complex is designed to reach the deepest layers of the vessel walls.

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug/pharmaceutical agent across the luminal surfaces of blood vessels.

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